A Phase 2 interventional study of docetaxel and cisplatin in Squamous Cell Carcinoma of the Head and Neck and Human Papilloma Virus, sponsored by Dana-Farber Cancer Institute. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-12-06.
Sponsored by Dana-Farber Cancer Institute · Phase 2, Interventional, and Treatment
In this research study, the investigators are studying whether a reduced dose of radiation when given with standard doses of chemotherapy can reduce side effects without compromising control of the cancer. An approved treatment for squamous cell carcinoma of the head and neck is initial chemotherapy followed by radiation and chemotherapy together. This treatment is effective but has many immediate and long-term side effects. People who have squamous cell carcinoma of the head and neck (SSCHN) that is related to an infection by the human papillomavirus (HPV) have been shown to have a high response to this treatment along with a high cure rate. The investigators think that by reducing the intensity of this treatment, they may be able to reduce immediate and long-term side effects which may lead to long term improvements in quality of life and function.
OBJECTIVES:
Primary
To determine rate of local-regional control at 2 years
Secondary
To determine Progression Free Survival at 2 and 5 years
To determine Overall Survival at 2 and 5 years
To assess acute toxicity and long term toxicity of reduced radiation dose at 2 and 5 years
6,738 studies on the registry are indexed under Carcinoma; 1,159 are open to participants now.
This study's enrollment of 7 is below the median of 45 across 5,167 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Dana-Farber Cancer Institute is the lead sponsor of 813 studies on the registry; 123 are open to participants now.
Of its 113 completed or terminated interventional studies of FDA-regulated products, 77 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria
Patients received 3 cycles (21 days each) of TPF induction chemotherapy: docetaxel 75 mg/m2 IV day 1; cisplatin 100 mg/m2 IV day 1 (carboplatin substitute permitted); 5-FU 1000 mg/m2/day IV pump continuous days 1-4. Concurrent chemoradiotherapy followed 4-6 weeks after day 1 of cycle 3 TPF induction: cetuximab 400 mg/m2 IV loading dose 1 week prior and 250 mg/m2 IV weekly (panitumumab substitute permitted); carboplatin AUC 1.5 (Calvert formula) IV weekly; Intensity modulated radiation therapy (IMRT)-response based dosing for 6-7 weeks.
Drug: docetaxel · Drug: cisplatin · Drug: 5-FU · Radiation: IMRT · Drug: cetuximab · Drug: carboplatin
Also known as: Taxotere, Docefrez
Given intravenously on day 1 of each cycle
Also known as: Platinol-AQ
Also known as: 5-fluorouracil
Also known as: Intensity modulated radiation therapy
Also known as: Erbitux
Also known as: Paraplatin
2-Year Local-Regional Control Rate
2-year local-regional control rate is defined as the proportion of participants who achieve confirmed stable disease (SD) or better by 2-years post study registration based on RECIST 1.0 criteria. Per RECIST 1.0 for target lesions, complete response (CR) is disappearance of all target lesions and partial response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. Progressive disease (PD) is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started. SD is neither PR nor PD. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Time frame: Follow-up for response continued until first progression. Disease assessments occurred at completion of induction cycle 3 along with months 12, 18 and 24 post study registration.
4-y Overall Survival Rate
4-year overall survival rate is the percentage of patients remaining alive 4-years from study entry.
Time frame: Patients were followed for survival up to 5 years from study entry. Patients alive have been followed for a mean of 55 months (range 52-60 months).
7 participants were enrolled between July 2011 and May 2012.
| Milestone | TPF Induction Chemotherapy Followed by Chemoradiotherapy |
|---|---|
| Started | 7 |
| Completed | 6 |
| Not completed | 1 |
| Withdrew: Adverse event | 1 |
2-year local-regional control rate is defined as the proportion of participants who achieve confirmed stable disease (SD) or better by 2-years post study registration based on RECIST 1.0 criteria. Per RECIST 1.0 for target lesions, complete response (CR) is disappearance of all target lesions and partial response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. Progressive disease (PD) is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started. SD is neither PR nor PD. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
No measurements were reported for this outcome.
4-year overall survival rate is the percentage of patients remaining alive 4-years from study entry.
| percentage of participants | TPF Induction Chemotherapy Followed by Chemoradiotherapy |
|---|---|
| 4-y Overall Survival Rate | 100 |
Collected over Assessed each cycle throughout induction, weekly during chemoradiotherapy and until outstanding adverse events are stable or resolved. All patients completed treatment (3 cycles of TPF induction and 7 weeks of chemoradiotherapy). AEs with treatment-attribution of possibly, probably or definitely were classified as serious if maximum grade 3-5 or other if grade 1-2 per CTCAEv4.There is no accessible AE data at this point.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| TPF Induction Chemotherapy Followed by Chemoradiotherapy | — | — | — |
| Age, Categorical(Participants) | TPF Induction Chemotherapy Followed by Chemoradiotherapy |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 7 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | TPF Induction Chemotherapy Followed by Chemoradiotherapy |
|---|---|
| Female | 0 |
| Male | 7 |
| Ethnicity (NIH/OMB)(Participants) | TPF Induction Chemotherapy Followed by Chemoradiotherapy |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 6 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | TPF Induction Chemotherapy Followed by Chemoradiotherapy |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 6 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(participants) | TPF Induction Chemotherapy Followed by Chemoradiotherapy |
|---|---|
| United States | 7 |
Plan to share: No — There is no data available.
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Dana-Farber Cancer Institute