CompletedNCT02573493APAUpdated Dec 27, 2024Results posted

Nab-Paclitaxel and Cisplatin or Nab-paclitaxel as Induction Therapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck (HNSCC)

A Phase 2 interventional study of nab-Paclitaxel and Cisplatin in Squamous Cell Carcinoma of the Head and Neck, Carcinoma, Squamous Cell of the Head and Neck and Cancer of Head and Neck, sponsored by Washington University School of Medicine. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-27.

Sponsored by Washington University School of Medicine · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 96
Allocation: Non-randomized
Ages: 18 Years and older
Sex: All

Study summary

In this trial, the objectives are to determine the efficacy and toxicity of induction chemotherapy (IC) with nab-paclitaxel + cisplatin (Arm 1: AP) and with nab-paclitaxel (Arm 2: A) alone in patients with HNSCC, and to compare these data to nab-paclitaxel, cisplatin, and 5-FU (APF). The investigators also hypothesize that the high anti-tumor efficacy of nab-paclitaxel in HNSCC is due to the upregulation of macropinocytosis, a result of the frequent presence of Ras and PI3K (and epidermal growth factor receptor -EGFR) activation in this cancer.

Amendment to Add Arm 3:

In this amendment, the investigators retain the AP + concurrent chemoradiation therapy (CRT) backbone but de-escalate the dose of radiation therapy (RT) from 70 Gy to 42 Gy. The investigators also plan to administer one dose (vs three) of cisplatin during RT. This novel treatment approach will be evaluated in patients with HPV-related oropharyngeal squamous cell carcinoma (OPSCC) (Arm 3), a sub-group with a very favorable prognosis.

Conditions studied

Squamous Cell Carcinoma of the Head and Neck
Carcinoma, Squamous Cell of the Head and Neck
Cancer of Head and Neck
Cancer of the Head and Neck
Head and Neck Cancer
Neoplasms, Head and Neck

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In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 96 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.

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Lead sponsor

Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.

Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

Inclusion Criteria: Arms 1 and 3 - AP

Diagnosis of selected Stage III or IVa/b HNSCC. Arm 1: T2-T4 primary tumors. Arm 3: T2T1-T4 primary tumors. Although most of these patients will have regional nodal disease, patients with no nodal disease will also be eligible.
Arm 1: Presence of disease at the oropharynx, hypopharynx, or larynx sub-sites.
Arm 3: Presence of disease at the oropharynx sub-sites, which is HPV-related as verified by p16, a surrogate marker of HPV, or HPV ISH or PCR.
Presence of measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm with CT scan.
At least 18 years of age.
Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry, for the duration of study participation, and for 3 months after completing treatment. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
Able to understand and willing to sign an IRB-approved written informed consent document.
ECOG performance status ≤ 1.
Adequate bone marrow and organ function as defined below:
- ANC: ≥ 1500/mcL.
- Platelets: > 100,000/mcL.
- Hemoglobin > 9.0 g/dL
- Total bilirubin ≤ 1.5 mg/dL
- AST/ALT/alkaline phosphatase: ≤ 2.5 x ULN.
- Serum creatinine: \< 1.5 mg/dL or calculated GFR ≥ 75 cc/min. CrCl by Cockcroft Gault will be used to estimate GFR.
- Pulmonary: no requirement for supplemental oxygen and no evidence of moderate-severe chronic obstructive pulmonary disease (COPD) by pulmonary function tests (PFTs).

Inclusion Criteria: Arm 2 - A

Diagnosis of selected Stage III or IVa/b HNSCC. T2-T4 primary tumors. (Patients with T1 tumors will be excluded). Although most of these patients will have regional nodal disease, patients with no nodal disease will also be eligible.
Presence of disease at the oropharynx, hypopharynx, or larynx sub-sites.
Presence of measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm with CT scan.
At least 18 years of age.
Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry, for the duration of study participation, and for 3 months after completing treatment. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
Able to understand and willing to sign an IRB-approved written informed consent document.
ECOG performance status \< 3.
Adequate bone marrow and organ function as defined below:
- ANC: ≥ 1500/mcL.
- Platelets: ≥ 100,000/mcL.
- Hemoglobin > 9.0 g/dL
- Total bilirubin ≤ 2.0 mg/dL
- AST/ALT/alkaline phosphatase: ≤ 5x ULN.
- Calculated GFR >30 cc/min. CrCl by Cockcroft Gault will be used to estimate GFR.
- Pulmonary: patients with a requirement for supplemental oxygen or evidence of moderate-severe COPD by PFTs are permitted to enroll.
If a patient fully meets criteria for Arm 1, but has profound hearing loss and the physician feels that the patient should not receive Cisplatin, the patient will be eligible for Arm 2.
If a patient fully meets criteria for Arm 1, but has a history of solid organ or bone marrow transplant, the patient will be eligible for Arm 2 (due to contraindications of Cisplatin with medications the patient is taking due to the transplant).

Exclusion Criteria (Arm 1 and Arm 2)

Prior chemotherapy, prior EGFR targeted therapy, or prior radiation therapy for HNSCC.
Disease at the nasopharyngeal, sinus, oral cavity, or other sub-site not specified as eligible.
Diagnosis of unknown primary squamous cell carcinoma of the head and neck.
History of prior invasive malignancy diagnosed within 3 years prior to study enrollment; exceptions are malignancies with a negligible risk of metastasis or death (e.g., expected 5-year OS > 90%) that were treated with an expected curative outcome, such as squamous cell carcinoma of the skin, in-situ carcinoma of the cervix uteri, non-melanomatous skin cancer, carcinoma in situ of the breast, or incidental histological finding of prostate cancer (TNM stage of T1a or T1b)
Receiving any other investigational agents.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to any of the agents used in this study.
Taking cimetidine or allopurinol. If currently taking either of these medications, patient must discontinue for one week before receiving treatment with nab-paclitaxel.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active serious infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or serious psychiatric illness/social situations that would limit compliance with study requirements.
Pregnant and/or breastfeeding. A negative serum or urine pregnancy test is required at screening for all female patients of childbearing potential.
Known to be HIV-positive on combination antiretroviral therapy because of the potential for pharmacokinetic interactions with the study agents. In addition, these patients are at increased risk of lethal infections when treated with marrow suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
Peripheral neuropathy > grade 1.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 96 participants (actual)

Study arms

Experimental
Arm 1: nab-Paclitaxel and cisplatin (AP) + CRT
* Six weeks of nab-paclitaxel (100 mg/m2/week) and cisplatin (75 mg/m2 days 1 and 22) followed by primary tumor site (PTS) assessment * If complete response (CR)/partial response (PR), three more weeks of nab-paclitaxel and cisplatin followed by concurrent chemoradiation therapy (CRT) * If \<PR, move directly to CRT if not surgical candidates. * CRT includes cisplatin which will begin 1 to 35 days after the completion of cycle 3. The first dose of cisplatin will be given during the initial 5 days of definitive radiation therapy, the second on approximately Day 22 of radiation, and the third on approximately Day 43 of radiation. * It is strongly recommended that intensity-modulated radiation therapy (IMRT) begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.
Drug: nab-Paclitaxel · Drug: Cisplatin · Radiation: Intensity-Modulated Radiation Therapy
Experimental
Arm 2: nab-Paclitaxel (A) + CRT
* Six weeks of nab-paclitaxel (100 mg/m2/week) followed by primary tumor site (PTS) assessment * If CR/PR, three more weeks of nab-paclitaxel followed by CRT * If \<PR, move directly to CRT if not surgical candidates. * CRT includes cetuximab and will begin 1 to 35 days after completion of cycle -Cetuximab will be started 7 days before starting definitive radiation therapy. The initial loading dose of cetuximab will be 400 mg/m\^2. Subsequently, cetuximab will be given weekly at a dose of 250 mg/m\^2 for seven additional doses concurrently with radiation therapy. * It is strongly recommended that IMRT begin within 21 to 42 days (no later than 56 days) after the start of cycle 3. The total dose will be 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to areas considered to be an intermediate risk.
Drug: nab-Paclitaxel · Biological: Cetuximab · Radiation: Intensity-Modulated Radiation Therapy
Experimental
Arm 3: nab-Paclitaxel and cisplatin (AP) + modified CRT
* 6 weeks of nab-paclitaxel and cisplatin (days 1 \& 22) followed by primary tumor site assessment * If CR/PR, cycle 3 of induction then 42Gy radiation, 1 dose of cisplatin or 6 doses cetuximab * If SD/PD: undergo surgery if candidate followed by CRT with 42 Gy RT and abbreviated cisplatin or cetuximab or 70Gy RT and 3 cycles of cisplatin or 8 doses of cetuximab * CRT includes Cisplatin and will begin 1-35 days after the completion of Cycle 3 of induction. Cisplatin will be given as 1 dose during the initial 5 days of definitive radiation therapy * Strongly recommended that radiation therapy begin within 28-49 days (and no later than 56 days) after the start of Cycle 3. Intensity modulated radiation therapy is to be used exclusively for this study.
Drug: nab-Paclitaxel · Drug: Cisplatin · Radiation: Intensity-Modulated Radiation Therapy

Interventions

Drugnab-Paclitaxel
Also known as: Abraxane
DrugCisplatin
Also known as: cis-DDP, cis-Platinum II, cis-Diamminedichloroplatinum, DDP
BiologicalCetuximab
Also known as: Erbitux®
RadiationIntensity-Modulated Radiation Therapy
Also known as: IMRT

What researchers measure

Primary outcomes

Arm 1 and Arm 2: Clinical Complete Response Rate as Measured by Clinical Exam at the Primary Tumor Site
* Assessment of primary tumor site will be done by laryngoscopy performed in the office or in the operating room. The primary tumor response to the first two cycles of induction will be assessed using visual categorical response. The percent change from baseline will be dictated in the ear, nose, and throat (ENT) physician's clinical exam note. * Complete response = complete resolution - 100% decrease/minimal residual mucosal abnormality
Time frame: Completion of 2 cycles (approximately 6 weeks)
Arm 3: Median Percent Weight Loss
Time frame: Completion of treatment (estimated to be 11-15 weeks)

Secondary outcomes

Arms 1, 2, and 3: Clinical Partial Response Rate as Measured by Clinical Exam at the Primary Tumor Site
* Assessment of primary tumor site will be done by laryngoscopy performed in the office or in the operating room. The primary tumor response to the first two cycles of induction will be assessed using visual categorical response. The percent change from baseline will be dictated in the ENT physician's clinical exam note. * Partial response - 99-50% decrease
Time frame: Completion of 2 cycles (approximately 6 weeks)
Arms 1, 2 and 3: Clinical Complete Response Rate as Measured by Clinical Exam at the Involved Regional Nodes
* The involved neck node response to the first two cycles of induction will be assessed using visual categorical response. The neck node measurements will be performed clinically by the treating medical oncology physician and dictated in his/her assessment note. * Complete response - complete resolution - 100% decrease/minimal residual mucosal abnormality
Time frame: Completion of 2 cycles (approximately 6 weeks)
Arms 1, 2, and 3: Clinical Partial Response Rate as Measured by Clinical Exam at the Involved Regional Nodes
* The involved neck node response to the first two cycles of induction will be assessed using visual categorical response. The neck node measurements will be performed clinically by the treating medical oncology physician and dictated in his/her assessment note. * Partial response - 99%-50% decrease
Time frame: Completion of 2 cycles (approximately 6 weeks)
Arms 1, 2, and 3: Anatomic Tumor Response as Assessed by CT Using RECIST 1.1 Criteria
-Computed tomography (CT) scan (intravenous contrast preferred) to document and measure the extent of the primary tumor size and involved regional neck nodes. RECIST 1.1 will be used to determine response at the primary tumor site, at the involved regional neck nodes and the radiographic overall tumor response.
Time frame: Completion of 2 cycles (approximately 6 weeks)
Arms 1, 2, and 3: Document and Quantify Ki-67 Expression by IHC in Primary Tumor Tissue and Correlate With Clinical Primary Tumor Site Response
Time frame: Completion of 2 cycles (approximately 6 weeks)
Arms 1, 2, and 3: Number of Participants Who Experienced a Grade 3-4 Adverse Event as Measured by NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Compare to those observed with APF with the objective that Arm 1 will be at least 25% lower than the risk of Grade 3-4 AE's during APF (40% decreased to 30%) and Arm 2 will be at least 50% lower than the risk of Grade 3-4 AE's during APF (40% decreased to 20%).
Time frame: 30 days after completion of treatment (estimated to be 15-25 weeks)
Arms 1, 2, and 3: Mean Total Score as Measured by the FACT/GOG-NTX-4
-The FACT/GOG-NTX-4 questionnaire has 4 questions about neuropathy (numbness/tingling in hands/feet and discomfort in hands/feet) with answers ranging from 0 (Not at all) to 4 (Very Much). The total score ranges from 0 to 16. A lower score indicates less neuropathy symptoms.
Time frame: Baseline and one year after completion of treatment (approximately 74 weeks)
Arms 1, 2, and 3: Mean Total Score as Measured by FACT-H&N
-The FACT-H\&N has 5 domains with 39 items including physical well-being (PWB), social/family well being (SWB), emotional well-being (EWB), functional well-being (FWB), and head \& neck cancer (HNCS) with answers ranging from 0 (Not at all) to 4 (Very Much). The PWB subscale score ranges from 0-28. The SWB subscale score ranges from 0-28. The EWB subscale score ranges from 0-24. The FWB subscale score ranges from 0-28. The HNCS subscale score ranges from 0-40. To obtain the total score all subscales are added together. The total score ranges from 0-148 with a higher score indicating a better quality of life.
Time frame: Baseline and one year after completion of treatment (approximately 74 weeks)
Arms 1, 2, and 3: Kaplan-Meier Estimate of Overall Survival (OS)
OS: duration of time from date of diagnosis to late date alive or time of death from any cause.
Time frame: Through one year after completion of treatment (approximately 74 weeks)
Arms 1, 2, and 3: Kaplan-Meier Estimate of Overall Survival (OS)
OS: duration of time from date of diagnosis to last date alive or time of death from any cause.
Time frame: Through 2 years after completion of treatment (estimated to be 2 years and 22 weeks)
Arms 1, 2, and 3: Kaplan-Meier Estimate of Disease-free Survival (DFS)
DFS: duration of time from last date of treatment to time of disease progression or death from any cause.
Time frame: Through one year after completion of treatment (approximately 74 weeks)
Arms 1, 2, and 3: Kaplan-Meier Estimate of Disease-free Survival (DFS)
DFS: duration of time from last date of treatment to time of disease progression or death from any cause.
Time frame: Through 2 years after completion of treatment (estimated to be 2 years and 22 weeks)
Arms 1, 2, and 3: Kaplan-Meier Estimate of Progression-free Survival (PFS)
◦PFS: duration of time from date of diagnosis to time of disease progression or death from any cause, whichever occurs first.
Time frame: Through one year after completion of treatment (approximately 74 weeks)
Arms 1, 2, and 3: Kaplan-Meier Estimate of Progression-free Survival (PFS)
◦PFS: duration of time from date of diagnosis to time of disease progression or death from any cause, whichever occurs first.
Time frame: Through 2 years after completion of treatment (estimated to be 2 years and 22 weeks)
Arm 3: Clinical Complete Response Rate as Measured by Clinical Exam at the Primary Tumor Site
* Assessment of primary tumor site will be done by laryngoscopy performed in the office or in the operating room. The primary tumor response to the first two cycles of induction will be assessed using visual categorical response. The percent change from baseline will be dictated in the ear, nose, and throat (ENT) physician's clinical exam note. * Complete response = complete resolution - 100% decrease/minimal residual mucosal abnormality
Time frame: Completion of 2 cycles (approximately 6 weeks)
Arm 1 and Arm 3: Comparison of Response Rate
-Stratified for HPV status
Time frame: Completion of 2 cycles (approximately 6 weeks)
Arm 1 and Arm 3: Comparison of the Rate of Grade 3/4 Adverse Events
Time frame: 30 days after completion of treatment (estimated to be 15-25 weeks)
Comparison of Median Absolute Weight Loss in Arms 2 and 3 to Arm 1
Time frame: From start of radiation treatment through completion of radiation treatment (estimated to be 7 weeks)
Comparison of Median Percent Weight Loss in Arms 2 and 3 to Arm 1
Time frame: From start of radiation treatment through completion of radiation treatment (estimated to be 7 weeks)
Arms 1, 2, and 3: Kaplan-Meier Estimate of Overall Survival (OS)
OS: duration of time from start of treatment to time of death from any cause
Time frame: Up to 5 years after completion of treatment (estimated to be 5 years and 22 weeks)
Arms 1, 2, and 3: Kaplan-Meier Estimate of Progression-free Survival (PFS)
◦PFS: duration of time from start of treatment to time of progression or death, whichever occurs first.
Time frame: Up to 5 years after completion of treatment (estimated to be 5 years and 22 weeks)
Arms 1, 2, and 3: Kaplan-Meier Estimate of Disease-free Survival (DFS)
Time frame: Through 5 years after completion of treatment (estimated to be 5 years and 22 weeks)
Arm 1 and Arm 3: Kaplan-Meier Estimate of Overall Survival
Time frame: Through 5 years after completion of treatment (estimated to be 5 years and 22 weeks)
Arm 1 and Arm 3: Kaplan-Meier Estimate of Disease-free Survival
Time frame: Through 5 years after completion of treatment (estimated to be 5 years and 22 weeks)
Arm 1 and Arm 3: Kaplan-Meier Estimate of Progression-free Survival
Time frame: Through 5 years after completion of treatment (estimated to be 5 years and 22 weeks)

Results

Posted Mar 2, 2021

Participant flow

Participant flow — Overall Study
Milestone	Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT	Arm 2: Nab-Paclitaxel (A) + CRT	Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT	Not Enrolled in Any Arm
Started	40	40	15	1
Completed	40	40	15	0
Not completed	0	0	0	1
Withdrew: Determined to not be eligible after enrollment	0	0	0	1

Outcome measures

PrimaryArm 1 and Arm 2: Clinical Complete Response Rate as Measured by Clinical Exam at the Primary Tumor Site

* Assessment of primary tumor site will be done by laryngoscopy performed in the office or in the operating room. The primary tumor response to the first two cycles of induction will be assessed using visual categorical response. The percent change from baseline will be dictated in the ear, nose, and throat (ENT) physician's clinical exam note. * Complete response = complete resolution - 100% decrease/minimal residual mucosal abnormality

Time frame:: Completion of 2 cycles (approximately 6 weeks)
Reported as:: Count of participants · Participants

Arm 1 and Arm 2: Clinical Complete Response Rate as Measured by Clinical Exam at the Primary Tumor Site
Participants	Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT	Arm 2: Nab-Paclitaxel (A) + CRT	Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT
Arm 1 and Arm 2: Clinical Complete Response Rate as Measured by Clinical Exam at the Primary Tumor Site	28	8	—

PrimaryArm 3: Median Percent Weight Loss

Time frame:: Completion of treatment (estimated to be 11-15 weeks)
Reported as:: Median · percentage of weight loss

Arm 3: Median Percent Weight Loss
percentage of weight loss	Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT	Arm 2: Nab-Paclitaxel (A) + CRT	Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT
Arm 3: Median Percent Weight Loss	—	—	6.7 (2.2 to 12.9)

SecondaryArms 1, 2, and 3: Clinical Partial Response Rate as Measured by Clinical Exam at the Primary Tumor Site

* Assessment of primary tumor site will be done by laryngoscopy performed in the office or in the operating room. The primary tumor response to the first two cycles of induction will be assessed using visual categorical response. The percent change from baseline will be dictated in the ENT physician's clinical exam note. * Partial response - 99-50% decrease

Time frame:: Completion of 2 cycles (approximately 6 weeks)
Reported as:: Count of participants · Participants

Arms 1, 2, and 3: Clinical Partial Response Rate as Measured by Clinical Exam at the Primary Tumor Site
Participants	Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT	Arm 2: Nab-Paclitaxel (A) + CRT	Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT
Arms 1, 2, and 3: Clinical Partial Response Rate as Measured by Clinical Exam at the Primary Tumor Site	11	28	6

SecondaryArms 1, 2 and 3: Clinical Complete Response Rate as Measured by Clinical Exam at the Involved Regional Nodes

* The involved neck node response to the first two cycles of induction will be assessed using visual categorical response. The neck node measurements will be performed clinically by the treating medical oncology physician and dictated in his/her assessment note. * Complete response - complete resolution - 100% decrease/minimal residual mucosal abnormality

Time frame:: Completion of 2 cycles (approximately 6 weeks)
Reported as:: Count of participants · Participants

Arms 1, 2 and 3: Clinical Complete Response Rate as Measured by Clinical Exam at the Involved Regional Nodes
Participants	Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT	Arm 2: Nab-Paclitaxel (A) + CRT	Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT
Arms 1, 2 and 3: Clinical Complete Response Rate as Measured by Clinical Exam at the Involved Regional Nodes	18	14	3

SecondaryArms 1, 2, and 3: Clinical Partial Response Rate as Measured by Clinical Exam at the Involved Regional Nodes

Time frame:: Completion of 2 cycles (approximately 6 weeks)
Reported as:: Count of participants · Participants

Arms 1, 2, and 3: Clinical Partial Response Rate as Measured by Clinical Exam at the Involved Regional Nodes
Participants	Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT	Arm 2: Nab-Paclitaxel (A) + CRT	Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT
Arms 1, 2, and 3: Clinical Partial Response Rate as Measured by Clinical Exam at the Involved Regional Nodes	11	14	7

SecondaryArms 1, 2, and 3: Anatomic Tumor Response as Assessed by CT Using RECIST 1.1 Criteria

-Computed tomography (CT) scan (intravenous contrast preferred) to document and measure the extent of the primary tumor size and involved regional neck nodes. RECIST 1.1 will be used to determine response at the primary tumor site, at the involved regional neck nodes and the radiographic overall tumor response.

Time frame:: Completion of 2 cycles (approximately 6 weeks)
Reported as:: Count of participants · Participants

Arms 1, 2, and 3: Anatomic Tumor Response as Assessed by CT Using RECIST 1.1 Criteria
Participants	Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT	Arm 2: Nab-Paclitaxel (A) + CRT	Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT
Complete response	2	1	1
Partial response	22	20	13

SecondaryArms 1, 2, and 3: Document and Quantify Ki-67 Expression by IHC in Primary Tumor Tissue and Correlate With Clinical Primary Tumor Site Response

Time frame:: Completion of 2 cycles (approximately 6 weeks)

No measurements were reported for this outcome.

SecondaryArms 1, 2, and 3: Number of Participants Who Experienced a Grade 3-4 Adverse Event as Measured by NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0

Compare to those observed with APF with the objective that Arm 1 will be at least 25% lower than the risk of Grade 3-4 AE's during APF (40% decreased to 30%) and Arm 2 will be at least 50% lower than the risk of Grade 3-4 AE's during APF (40% decreased to 20%).

Time frame:: 30 days after completion of treatment (estimated to be 15-25 weeks)
Reported as:: Count of participants · Participants

Arms 1, 2, and 3: Number of Participants Who Experienced a Grade 3-4 Adverse Event as Measured by NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Participants	Arm 1: Nab-Paclitaxel and Cisplatin (AP) Induction	Arm 2: Nab-Paclitaxel (A) Induction	Arm 3: Nab-Paclitaxel and Cisplatin (AP) Induction	Arm 1 CRT: Cisplatin + Radiation Therapy	Arm 1 & 2 ERT: Cetuximab + Radiation Therapy	Arm 3 CR: Cisplatin + Radiation Therapy
Arms 1, 2, and 3: Number of Participants Who Experienced a Grade 3-4 Adverse Event as Measured by NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0	23	17	4	37	35	4

SecondaryArms 1, 2, and 3: Mean Total Score as Measured by the FACT/GOG-NTX-4

-The FACT/GOG-NTX-4 questionnaire has 4 questions about neuropathy (numbness/tingling in hands/feet and discomfort in hands/feet) with answers ranging from 0 (Not at all) to 4 (Very Much). The total score ranges from 0 to 16. A lower score indicates less neuropathy symptoms.

Time frame:: Baseline and one year after completion of treatment (approximately 74 weeks)
Reported as:: Mean · score on a scale

Arms 1, 2, and 3: Mean Total Score as Measured by the FACT/GOG-NTX-4
score on a scale	Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT	Arm 2: Nab-Paclitaxel (A) + CRT	Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT
Baseline	0.19 (0.02 to 0.36)	0.38 (0.18 to 0.59)	0.27 (0.04 to 0.57)
End of treatment	1.55 (1.09 to 2.01)	0.91 (0.40 to 1.33)	1.54 (0.90 to 2.18)

SecondaryArms 1, 2, and 3: Mean Total Score as Measured by FACT-H&N

-The FACT-H\&N has 5 domains with 39 items including physical well-being (PWB), social/family well being (SWB), emotional well-being (EWB), functional well-being (FWB), and head \& neck cancer (HNCS) with answers ranging from 0 (Not at all) to 4 (Very Much). The PWB subscale score ranges from 0-28. The SWB subscale score ranges from 0-28. The EWB subscale score ranges from 0-24. The FWB subscale score ranges from 0-28. The HNCS subscale score ranges from 0-40. To obtain the total score all subscales are added together. The total score ranges from 0-148 with a higher score indicating a better quality of life.

Time frame:: Baseline and one year after completion of treatment (approximately 74 weeks)
Reported as:: Mean · score on a scale

Arms 1, 2, and 3: Mean Total Score as Measured by FACT-H&N
score on a scale	Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT	Arm 2: Nab-Paclitaxel (A) + CRT	Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT
Baseline	2.02 (1.93 to 2.11)	1.86 (1.74 to 1.97)	2.07 (1.94 to 2.20)
End of treatment	1.98 (1.89 to 2.06)	1.82 (1.71 to 1.93)	2.00 (1.86 to 2.15)

SecondaryArms 1, 2, and 3: Kaplan-Meier Estimate of Overall Survival (OS)

OS: duration of time from date of diagnosis to late date alive or time of death from any cause.

Time frame:: Through one year after completion of treatment (approximately 74 weeks)
Reported as:: Number · percentage of particpants

Arms 1, 2, and 3: Kaplan-Meier Estimate of Overall Survival (OS)
percentage of particpants	Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT	Arm 2: Nab-Paclitaxel (A) + CRT	Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT
Arms 1, 2, and 3: Kaplan-Meier Estimate of Overall Survival (OS)	100	87.50	92.31

SecondaryArms 1, 2, and 3: Kaplan-Meier Estimate of Overall Survival (OS)

OS: duration of time from date of diagnosis to last date alive or time of death from any cause.

Time frame:: Through 2 years after completion of treatment (estimated to be 2 years and 22 weeks)
Reported as:: Number · percentage of participants

Arms 1, 2, and 3: Kaplan-Meier Estimate of Overall Survival (OS)
percentage of participants	Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT	Arm 2: Nab-Paclitaxel (A) + CRT	Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT
Arms 1, 2, and 3: Kaplan-Meier Estimate of Overall Survival (OS)	97.44	69.63	84.62

SecondaryArms 1, 2, and 3: Kaplan-Meier Estimate of Disease-free Survival (DFS)

DFS: duration of time from last date of treatment to time of disease progression or death from any cause.

Time frame:: Through one year after completion of treatment (approximately 74 weeks)
Reported as:: Number · percentage of participants

Arms 1, 2, and 3: Kaplan-Meier Estimate of Disease-free Survival (DFS)
percentage of participants	Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT	Arm 2: Nab-Paclitaxel (A) + CRT	Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT
Arms 1, 2, and 3: Kaplan-Meier Estimate of Disease-free Survival (DFS)	87.50	62.50	76.92

SecondaryArms 1, 2, and 3: Kaplan-Meier Estimate of Disease-free Survival (DFS)

DFS: duration of time from last date of treatment to time of disease progression or death from any cause.

Time frame:: Through 2 years after completion of treatment (estimated to be 2 years and 22 weeks)
Reported as:: Number · percentage of participants

Arms 1, 2, and 3: Kaplan-Meier Estimate of Disease-free Survival (DFS)
percentage of participants	Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT	Arm 2: Nab-Paclitaxel (A) + CRT	Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT
Arms 1, 2, and 3: Kaplan-Meier Estimate of Disease-free Survival (DFS)	87.50	51.81	69.23

SecondaryArms 1, 2, and 3: Kaplan-Meier Estimate of Progression-free Survival (PFS)

◦PFS: duration of time from date of diagnosis to time of disease progression or death from any cause, whichever occurs first.

Time frame:: Through one year after completion of treatment (approximately 74 weeks)
Reported as:: Number · percentage of participants

Arms 1, 2, and 3: Kaplan-Meier Estimate of Progression-free Survival (PFS)
percentage of participants	Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT	Arm 2: Nab-Paclitaxel (A) + CRT	Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT
Arms 1, 2, and 3: Kaplan-Meier Estimate of Progression-free Survival (PFS)	92.50	67.50	76.92

SecondaryArms 1, 2, and 3: Kaplan-Meier Estimate of Progression-free Survival (PFS)

◦PFS: duration of time from date of diagnosis to time of disease progression or death from any cause, whichever occurs first.

Time frame:: Through 2 years after completion of treatment (estimated to be 2 years and 22 weeks)
Reported as:: Number · percentage of participants

Arms 1, 2, and 3: Kaplan-Meier Estimate of Progression-free Survival (PFS)
percentage of participants	Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT	Arm 2: Nab-Paclitaxel (A) + CRT	Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT
Arms 1, 2, and 3: Kaplan-Meier Estimate of Progression-free Survival (PFS)	87.43	54.89	69.23

SecondaryArm 3: Clinical Complete Response Rate as Measured by Clinical Exam at the Primary Tumor Site

Time frame:: Completion of 2 cycles (approximately 6 weeks)
Reported as:: Count of participants · Participants

Arm 3: Clinical Complete Response Rate as Measured by Clinical Exam at the Primary Tumor Site
Participants	Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT	Arm 2: Nab-Paclitaxel (A) + CRT	Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT
Arm 3: Clinical Complete Response Rate as Measured by Clinical Exam at the Primary Tumor Site	—	—	9

SecondaryArm 1 and Arm 3: Comparison of Response Rate

-Stratified for HPV status

Time frame:: Completion of 2 cycles (approximately 6 weeks)

No measurements were reported for this outcome.

SecondaryArm 1 and Arm 3: Comparison of the Rate of Grade 3/4 Adverse Events

Time frame:: 30 days after completion of treatment (estimated to be 15-25 weeks)
Reported as:: Count of participants · Participants

Arm 1 and Arm 3: Comparison of the Rate of Grade 3/4 Adverse Events
Participants	Arm 1: Nab-Paclitaxel and Cisplatin (AP) Induction	Arm 3: Nab-Paclitaxel and Cisplatin (AP) Induction	Arm 1 CRT: Cisplatin + Radiation Therapy	Arm 3 CR: Cisplatin + Radiation Therapy
Arm 1 and Arm 3: Comparison of the Rate of Grade 3/4 Adverse Events	23	4	37	4

SecondaryComparison of Median Absolute Weight Loss in Arms 2 and 3 to Arm 1

Time frame:: From start of radiation treatment through completion of radiation treatment (estimated to be 7 weeks)
Reported as:: Median · kilograms

Comparison of Median Absolute Weight Loss in Arms 2 and 3 to Arm 1
kilograms	Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT	Arm 2: Nab-Paclitaxel (A) + CRT	Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT
Comparison of Median Absolute Weight Loss in Arms 2 and 3 to Arm 1	8.4 (3.1 to 20.8)	5.2 (4.9 to 14.6)	7.0 (1.7 to 12.8)

SecondaryComparison of Median Percent Weight Loss in Arms 2 and 3 to Arm 1

Time frame:: From start of radiation treatment through completion of radiation treatment (estimated to be 7 weeks)
Reported as:: Median · median percent of weight loss

Comparison of Median Percent Weight Loss in Arms 2 and 3 to Arm 1
median percent of weight loss	Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT	Arm 2: Nab-Paclitaxel (A) + CRT	Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT
Comparison of Median Percent Weight Loss in Arms 2 and 3 to Arm 1	9.1 (6.7 to 11.2)	6.6 (2.6 to 8.1)	6.7 (2.2 to 9.9)

SecondaryArms 1, 2, and 3: Kaplan-Meier Estimate of Overall Survival (OS)

OS: duration of time from start of treatment to time of death from any cause

Time frame:: Up to 5 years after completion of treatment (estimated to be 5 years and 22 weeks)
Reported as:: Number · percentage of participants

Arms 1, 2, and 3: Kaplan-Meier Estimate of Overall Survival (OS)
percentage of participants	Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT	Arm 2: Nab-Paclitaxel (A) + CRT	Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT
Arms 1, 2, and 3: Kaplan-Meier Estimate of Overall Survival (OS)	77.1	40.5	68.4

SecondaryArms 1, 2, and 3: Kaplan-Meier Estimate of Progression-free Survival (PFS)

◦PFS: duration of time from start of treatment to time of progression or death, whichever occurs first.

Time frame:: Up to 5 years after completion of treatment (estimated to be 5 years and 22 weeks)
Reported as:: Number · percentage of participants

Arms 1, 2, and 3: Kaplan-Meier Estimate of Progression-free Survival (PFS)
percentage of participants	Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT	Arm 2: Nab-Paclitaxel (A) + CRT	Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT
Arms 1, 2, and 3: Kaplan-Meier Estimate of Progression-free Survival (PFS)	77.2	33.8	69.2

SecondaryArms 1, 2, and 3: Kaplan-Meier Estimate of Disease-free Survival (DFS)

Time frame:: Through 5 years after completion of treatment (estimated to be 5 years and 22 weeks)
Reported as:: Number · percentage of participants

Arms 1, 2, and 3: Kaplan-Meier Estimate of Disease-free Survival (DFS)
percentage of participants	Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT	Arm 2: Nab-Paclitaxel (A) + CRT	Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT
Arms 1, 2, and 3: Kaplan-Meier Estimate of Disease-free Survival (DFS)	77.2	32.0	69.2

SecondaryArm 1 and Arm 3: Kaplan-Meier Estimate of Overall Survival

Time frame:: Through 5 years after completion of treatment (estimated to be 5 years and 22 weeks)
Reported as:: Number · percentage of participants

Arm 1 and Arm 3: Kaplan-Meier Estimate of Overall Survival
percentage of participants	Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT	Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT
Arm 1 and Arm 3: Kaplan-Meier Estimate of Overall Survival	77.1	68.4

SecondaryArm 1 and Arm 3: Kaplan-Meier Estimate of Disease-free Survival

Time frame:: Through 5 years after completion of treatment (estimated to be 5 years and 22 weeks)
Reported as:: Number · percentage of participants

Arm 1 and Arm 3: Kaplan-Meier Estimate of Disease-free Survival
percentage of participants	Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT	Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT
Arm 1 and Arm 3: Kaplan-Meier Estimate of Disease-free Survival	77.2	69.2

SecondaryArm 1 and Arm 3: Kaplan-Meier Estimate of Progression-free Survival

Time frame:: Through 5 years after completion of treatment (estimated to be 5 years and 22 weeks)
Reported as:: Number · percentage of participants

Arm 1 and Arm 3: Kaplan-Meier Estimate of Progression-free Survival
percentage of participants	Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT	Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT
Arm 1 and Arm 3: Kaplan-Meier Estimate of Progression-free Survival	77.2	69.2

Adverse events

Collected over -Adverse events were collected from start of treatment through 30 days following last day of study treatment. -All-cause mortality was collected from start of treatment until completion of follow-up (up to 72 months following completion of treatment).. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Arm 1: Nab-Paclitaxel and Cisplatin (AP) Induction	0/40 (0%)	6/40 (15%)	40/40 (100%)
Arm 2: Nab-Paclitaxel (A) Induction	0/40 (0%)	6/40 (15%)	40/40 (100%)
Arm 3: Nab-Paclitaxel and Cisplatin (AP) Induction	0/15 (0%)	2/15 (13.3%)	15/15 (100%)
Arm 1 CRT: Cisplatin + Radiation Therapy	0/34 (0%)	9/34 (26.5%)	34/34 (100%)
Arm 1 & 2 ERT: Cetuximab + Radiation Therapy	0/42 (0%)	6/42 (14.3%)	42/42 (100%)
Arm 3 CR: Cisplatin + Radiation Therapy	0/15 (0%)	2/15 (13.3%)	15/15 (100%)
Arm 1: Nab-Paclitaxel+Cisplatin+CRT Follow-up	9/40 (22.5%)	0/40 (0%)	—
Arm 2: Nab-Paclitaxel + ERT Follow-up	21/40 (52.5%)	1/40 (2.5%)	—
Arm 3: Nab-Paclitaxel+Cisplatin+Modified CRT Follow-up	4/15 (26.7%)	1/15 (6.7%)	—

Most frequent serious events

Showing 10 of 40

Most frequent serious events
Event	Arm 1: Nab-Paclitaxel and Cisplatin (AP) Induction	Arm 2: Nab-Paclitaxel (A) Induction	Arm 3: Nab-Paclitaxel and Cisplatin (AP) Induction	Arm 1 CRT: Cisplatin + Radiation Therapy	Arm 1 & 2 ERT: Cetuximab + Radiation Therapy	Arm 3 CR: Cisplatin + Radiation Therapy	Arm 1: Nab-Paclitaxel+Cisplatin+CRT Follow-up	Arm 2: Nab-Paclitaxel + ERT Follow-up	Arm 3: Nab-Paclitaxel+Cisplatin+Modified CRT Follow-up
NauseaGastrointestinal disorders	0/40	0/40	0/15	3/34	1/42	0/15	—	0/40	0/15
HypomagnesemiaMetabolism and nutrition disorders	0/40	0/40	1/15	1/34	0/42	0/15	—	0/40	0/15
DehydrationMetabolism and nutrition disorders	2/40	0/40	1/15	0/34	0/42	1/15	—	0/40	0/15
SyncopeNervous system disorders	1/40	0/40	0/15	0/34	0/42	1/15	—	0/40	0/15
CellulitisInfections and infestations	0/40	1/40	1/15	0/34	0/42	0/15	—	0/40	0/15
HypocalcemiaMetabolism and nutrition disorders	0/40	0/40	1/15	0/34	0/42	0/15	—	0/40	0/15
Death due to disease progression NOSNeoplasms benign, malignant and unspecified (incl cysts and polyps)	0/40	0/40	0/15	0/34	0/42	0/15	—	0/40	1/15
AnorexiaMetabolism and nutrition disorders	0/40	0/40	0/15	0/34	0/42	1/15	—	0/40	0/15
Catheter related infectionInfections and infestations	1/40	0/40	0/15	2/34	1/42	0/15	—	0/40	0/15
VomitingGastrointestinal disorders	1/40	0/40	0/15	2/34	0/42	0/15	—	0/40	0/15

Most frequent other events

Showing 10 of 235

Most frequent other events
Event	Arm 1: Nab-Paclitaxel and Cisplatin (AP) Induction	Arm 2: Nab-Paclitaxel (A) Induction	Arm 3: Nab-Paclitaxel and Cisplatin (AP) Induction	Arm 1 CRT: Cisplatin + Radiation Therapy	Arm 1 & 2 ERT: Cetuximab + Radiation Therapy	Arm 3 CR: Cisplatin + Radiation Therapy	Arm 1: Nab-Paclitaxel+Cisplatin+CRT Follow-up	Arm 2: Nab-Paclitaxel + ERT Follow-up	Arm 3: Nab-Paclitaxel+Cisplatin+Modified CRT Follow-up
Dry mouthGastrointestinal disorders	2/40	4/40	4/15	20/34	22/42	15/15	—	—	—
Mucositis oralGastrointestinal disorders	4/40	0/40	1/15	26/34	34/42	15/15	—	—	—
HemoglobinInvestigations	40/40	35/40	15/15	34/34	35/42	15/15	—	—	—
LymphopeniaInvestigations	24/40	25/40	8/15	34/34	35/42	12/15	—	—	—
LeukocytesInvestigations	27/40	25/40	12/15	30/34	11/42	8/15	—	—	—
DysgeusiaGastrointestinal disorders	7/40	4/40	9/15	17/34	17/42	13/15	—	—	—
DysphagiaGastrointestinal disorders	20/40	25/40	6/15	20/34	29/42	13/15	—	—	—
FatigueGeneral disorders	24/40	21/40	10/15	29/34	26/42	13/15	—	—	—
Neutropenia (ANC)Investigations	27/40	21/40	13/15	26/34	5/42	4/15	—	—	—
Weight lossInvestigations	8/40	9/40	4/15	29/34	27/42	8/15	—	—	—

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT	Arm 2: Nab-Paclitaxel (A) + CRT	Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT	Not Enrolled in Any Arm	Total
Median	57.5 (42 to 77)	65.5 (48 to 83)	61 (41 to 68)	62 (62 to 62)	61 (41 to 83)

Sex: Female, Male
Sex: Female, Male(Participants)	Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT	Arm 2: Nab-Paclitaxel (A) + CRT	Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT	Not Enrolled in Any Arm	Total
Female	4	8	1	1	14
Male	36	32	14	0	82

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT	Arm 2: Nab-Paclitaxel (A) + CRT	Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT	Not Enrolled in Any Arm	Total
Hispanic or Latino	0	0	0	0	0
Not Hispanic or Latino	40	39	15	1	95
Unknown or Not Reported	0	1	0	0	1

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT	Arm 2: Nab-Paclitaxel (A) + CRT	Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT	Not Enrolled in Any Arm	Total
American Indian or Alaska Native	0	0	0	0	0
Asian	0	0	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0	0	0
Black or African American	8	3	0	0	11
White	32	37	15	1	85
More than one race	0	0	0	0	0
Unknown or Not Reported	0	0	0	0	0

Region of Enrollment
Region of Enrollment(participants)	Arm 1: Nab-Paclitaxel and Cisplatin (AP) + CRT	Arm 2: Nab-Paclitaxel (A) + CRT	Arm 3: Nab-Paclitaxel and Cisplatin (AP) + Modified CRT	Not Enrolled in Any Arm	Total
United States	40	40	15	1	96

Study locations

3 sites

The University of Kansas Cancer Center and Medical Pavilion
Westwood, Kansas 66205, United States
Washington University School of Medicine
Saint Louis, Missouri 63110, United States
Sanford Cancer Center
Sioux Falls, South Dakota 57104, United States

References and documents

Publications

Oppelt P, Ley J, Daly M, Rich J, Paniello R, Jackson RS, Pipkorn P, Liu J, Gay H, Palka K, Neupane P, Powell S, Spanos WC, Gitau M, Zevallos J, Thorstad W, Adkins D. nab-Paclitaxel and cisplatin followed by cisplatin and radiation (Arm 1) and nab-paclitaxel followed by cetuximab and radiation (Arm 2) for locally advanced head and neck squamous-cell carcinoma: a multicenter, non-randomized phase 2 trial. Med Oncol. 2021 Mar 8;38(4):35. doi: 10.1007/s12032-021-01479-w. PubMed 33683482 ↗

Study documents

Protocol and statistical analysis plan · Mar 25, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02573493
Lead sponsor: Washington University School of Medicine
Collaborators: Celgene Corporation
Responsible party: Sponsor
First posted: Oct 9, 2015
Start date: Apr 13, 2016
Primary completion: Dec 12, 2019
Completion: Jul 1, 2024
Results posted: Mar 2, 2021
Last update: Dec 27, 2024

Study contacts

Douglas Adkins, M.D.

principal investigator · Washington University School of Medicine

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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Nab-Paclitaxel and Cisplatin or Nab-paclitaxel as Induction Therapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck (HNSCC)

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