Active, not recruitingNCT00334815Updated Aug 26, 2026Results posted

Combination Chemotherapy, Radiation Therapy, and Bevacizumab in Treating Patients With Newly Diagnosed Stage III Non-small Cell Lung Cancer That Cannot Be Removed by Surgery

A Phase 2 interventional study of Bevacizumab and Cisplatin in Lung Adenocarcinoma, Lung Adenosquamous Carcinoma and Lung Large Cell Carcinoma, sponsored by National Cancer Institute (NCI). Active, not recruiting at 61 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-26.

Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 29
Allocation: Non-randomized
Ages: 18 Years and older
Sex: All

Study summary

This clinical trial studies combination chemotherapy, radiation therapy, and bevacizumab in treating patients with newly diagnosed stage III non-small cell lung cancer that cannot be removed by surgery. Drugs used in chemotherapy, such as cisplatin, etoposide, and docetaxel, work in different ways to stop the growth of [cancer/tumor] cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving more than one drug (combination chemotherapy) together with radiation therapy and bevacizumab may kill more tumor cells.

Read the detailed description

PRIMARY OBJECTIVES:

I. Determine the frequency and severity of toxic effects of induction therapy comprising cisplatin, etoposide, and radiotherapy with or without bevacizumab followed by consolidation therapy comprising docetaxel and bevacizumab, in terms of grade 4 or 5 hemorrhage, in patients with newly diagnosed, unresectable, stage III non-small cell lung cancer.

SECONDARY OBJECTIVES:

I. Determine progression-free and overall survival of patients treated with these regimens.

II. Determine response (confirmed, unconfirmed, partial, and complete) in patients with measurable disease treated with these regimens.

OUTLINE: This is a pilot, multicenter study. Patients are stratified according to risk (high* vs low).

NOTE: *High-risk stratum closed to accrual as of 2/20/09.

INDUCTION THERAPY: Patients in each stratum are assigned to 1 of 3 sequential treatment groups.

GROUP 1: Patients receive cisplatin intravenously (IV) over 1 hour on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Patients undergo concurrent thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.

GROUP 2: Patients receive cisplatin, etoposide, and thoracic radiotherapy as in group 1. Patients also receive bevacizumab IV over 30-90 minutes on days 15, 36, and 57.

GROUP 3: Patients receive cisplatin, etoposide, and thoracic radiotherapy as in group 1. Patients also receive bevacizumab IV over 30-90 minutes on days 1, 22, and 43.

CONSOLIDATION CHEMOTHERAPY: Beginning 3-6 weeks after completion of induction therapy, all patients receive consolidation chemotherapy comprising docetaxel IV over 1 hour and bevacizumab IV over 30-90 minutes on day 1. Patients also receive filgrastim (G-CSF) subcutaneously (SC) beginning on day 2 and continuing until blood counts recover OR pegfilgrastim SC once on day 2.

Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically for up to 4 years.

Conditions studied

Lung Adenocarcinoma
Lung Adenosquamous Carcinoma
Lung Large Cell Carcinoma
Lung Squamous Cell Carcinoma
Minimally Invasive Lung Adenocarcinoma
Stage IIIA Lung Non-Small Cell Cancer AJCC v7
Stage IIIB Lung Non-Small Cell Cancer AJCC v7

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In context

Adenocarcinoma of Lung

303 studies on the registry are indexed under Adenocarcinoma of Lung; 78 are open to participants now.

This study's enrollment of 29 is below the median of 63 across 212 interventional studies indexed under Adenocarcinoma of Lung.

Browse Adenocarcinoma of Lung studies →

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.

Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) 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:

Histologically or cytologically confirmed single, primary, bronchogenic, non-small cell lung cancer (NSCLC)
- Newly diagnosed disease
- Unresectable disease
- No more than 1 parenchymal lesions on same or opposite sides of the lungs
Meets 1 of the following stage criteria:
- Stage IIIA (N2) disease meeting the following criteria:
  - N2 mediastinal lymph nodes must be multiple and/or bulky on CT scan or x-ray so that the patient is not a candidate for induction chemotherapy or chemoradiotherapy followed by surgical resection
  - N2 status must be documented by ≥ 1 of the following methods:
    - Histologically or cytologically confirmed N2 disease by exploratory thoracotomy, thoracoscopy, mediastinoscopy, mediastinotomy, Chamberlain procedure, Wang needle biopsy (WNB), fine needle aspiration (FNA) under bronchoscopic or CT guidance, or any other method
    - Node positive by fludeoxyglucose-positron emission tomography (FDG-PET) scan
    - Nodes > 3 cm on CT scan
    - Paralyzed left true vocal cord with separate left lung primary distinct from anterior-posterior window nodes on CT scan
- Stage IIIB disease meeting ≥ 1 of the following criteria:
  - Histologically or radiographically confirmed positive N3 nodes*, documented by ≥ 1 of the following methods:
    - FNA, core needle biopsy (CNB), or excisional biopsy of supraclavicular N3 nodes
    - Biopsy of contralateral mediastinal N3 nodes by mediastinoscopy, mediastinotomy, or thoracotomy
    - FNA, CNB, or WNB under CT or bronchoscopic fluoroscopic guidance of enlarged contralateral N3 mediastinal nodes
    - Contralateral mediastinal nodes > 3 cm on CT scan
    - Node positivity by FDG-PET scan
    - Right-sided primary with paralyzed left true vocal cord
  - T4 lesions of any size that invade the mediastinum, heart, great vessels, trachea, esophagus, vertebral body, or carina, documented by ≥ 1 of the following methods:
    - Written documentation of type of T4 extent if patient had a prior exploratory thoracotomy or thoracoscopy
    - T4 involvement of the trachea or carina by direct bronchoscopic visualization
    - T4 involvement of the heart, esophagus, aorta, or vertebral body by CT scan, MRI, or transesophageal ultrasound
    - T4 involvement of the mediastinum by CT scan or MRI if, in the absence of the above organ involvement, there is soft tissue extension directly into the mediastinal space**
Meets 1 of the following risk criteria:
- Low risk disease, meeting the following criteria:
  - Non-squamous cell NSCLC, including adenocarcinoma, bronchoalveolar cell carcinoma, or large cell carcinoma
    - If mixed histology, the squamous cell carcinoma component must be \< 50%
    - Histology or cytology from involved mediastinal or supraclavicular lymph nodes allowed if a separate distal primary lesion is clearly evident on radiographs (i.e., second biopsy not required)
  - No primary tumor with cavitation and/or tumor within 1 cm of a major vessel
  - No hemoptysis (i.e., bright red blood ≥ ½ teaspoon) in the past 28 days
- High-risk* disease, meeting ≥ 1 of the following criteria:
  - Squamous cell NSCLC
    - If mixed histology, the squamous cell component must be ≥ 50%
  - Tumor with any histology that has cavitation or is located within 1 cm of a major vessel
    - No aortic involvement
  - Any histology and hemoptysis (i.e., bright red blood ≥ ½ teaspoon) within past 28 days
Measurable or nonmeasurable disease by CT scan or MRI
- Pleural effusions, ascites, and laboratory parameters are not acceptable as the only evidence of disease
No pleural effusion except for small pleural effusion visible on CT scan or MRI alone
No pericardial effusions
No metastatic disease involving the contralateral chest, liver, or adrenals confirmed by CT scan of the upper abdomen or by chest CT scan with complete liver and adrenals in the report
Patients must be offered participation in SWOG-S9925 (Lung Cancer Specimen Repository Protocol)
No brain metastases by CT scan or MRI
No evidence of cavitation
Creatinine normal
Creatinine clearance ≥ 50 mL/min
FEV_1 ≥ 2.0 liters OR predicted FEV_1 of the contralateral lung > 800 mL
Absolute neutrophil count ≥ 1,500/mm\^3
Platelet count ≥ 100,000/mm\^3
Urine protein: creatinine ratio ≤ 0.5 by urinalysis OR urine protein \< 1,000 mg by 24-hour urine collection
INR \< 1.5
Zubrod performance status 0-1
No sensory neuropathy > grade 1
No cerebrovascular accident within the past 6 months
No myocardial infarction or unstable angina within the past 6 months
No uncontrolled hypertension
No New York Heart Association class II-IV congestive heart failure
No serious cardiac arrhythmia requiring medication
No clinically significant peripheral vascular disease
No evidence of bleeding diathesis or coagulopathy
No pathologic condition other than lung cancer that carries a high risk of bleeding
No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
No serious, nonhealing wound, ulcer, or bone fracture
No other prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer for which the patient is currently in complete remission, or other cancer for which the patient has been disease-free for 5 years
Not pregnant or nursing
- No nursing during and for ≥ 6 months after the last dose of bevacizumab
Negative pregnancy test
Fertile patients must use effective contraception during and for ≥ 6 months after the last dose of bevacizumab
Must have pre-treatment simulation demonstrating a V20 ≤ 35% with planned radiation dose of 6,480 cGy
No prior surgical resection
- Prior exploratory thoracotomy, mediastinoscopy, excisional biopsy, or similar surgery allowed for diagnosing, staging, or determining potential resectability of lung tumor
No prior chemotherapy or radiotherapy for lung cancer
No prior radiotherapy to the neck or thorax
At least 4 weeks since prior thoracic or other major surgery (excluding mediastinoscopy) and recovered
More than 7 days since prior FNA, CNB, or mediastinoscopy
No other concurrent anticancer therapy, including chemotherapy, radiotherapy, or biologic agents
No other concurrent investigational drugs
No concurrent major surgical procedures
No concurrent full-dose anticoagulants (e.g., low-molecular weight and unfractionated heparin or warfarin)
- Low-dose warfarin (i.e., 1 mg) is allowed to prevent clotting of an infusaport or central line
No concurrent brachytherapy, radiopharmaceuticals, high linear energy transfer radiation (i.e., fast neutrons), particle therapy (i.e., protons, carbon, or helium), and/or altered fractionation schemes
No concurrent intensity-modulated radiotherapy
No concurrent prophylactic contralateral hilar or supraclavicular lymph node radiotherapy

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 29 participants (actual)

Study arms

Experimental
Group 1 (cisplatin, etoposide, radiotherapy)
Patients receive cisplatin IV over 1 hour on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Patients undergo concurrent thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.
Drug: Cisplatin · Drug: Docetaxel · Drug: Etoposide · Biological: Filgrastim · Biological: Pegfilgrastim · Radiation: Radiation Therapy
Experimental
Group 2 (cisplatin, etoposide, radiotherapy, bevacizumab)
Patients receive cisplatin, etoposide, and thoracic radiotherapy as in group 1. Patients also receive bevacizumab IV over 30-90 minutes on days 15, 36, and 57.
Biological: Bevacizumab · Drug: Cisplatin · Drug: Docetaxel · Drug: Etoposide · Biological: Filgrastim · Biological: Pegfilgrastim · Radiation: Radiation Therapy
Experimental
Group 3 (cisplatin, etoposide, radiotherapy, bevacizumab)
Patients receive cisplatin, etoposide, and thoracic radiotherapy as in group 1. Patients also receive bevacizumab IV over 30-90 minutes on days 1, 22, and 43.
Biological: Bevacizumab · Drug: Cisplatin · Drug: Docetaxel · Drug: Etoposide · Biological: Filgrastim · Biological: Pegfilgrastim · Radiation: Radiation Therapy

Interventions

BiologicalBevacizumab
Given IV
Also known as: ABP 215, ABP-215, ABP215, Alymsys, Anti-VEGF, Anti-VEGF Humanized Monoclonal Antibody, Anti-VEGF Monoclonal Antibody SIBP04, Anti-VEGF rhuMAb, Avastin, Avegra, Avzivi, Aybintio, BAT 1706, BAT-1706, BAT1706, BAT1706 Biosimilar, Bevacizumab awwb, Bevacizumab Biosimilar ABP 215, Bevacizumab Biosimilar BAT1706, Bevacizumab Biosimilar BEVZ92, Bevacizumab Biosimilar BI 695502, Bevacizumab Biosimilar CBT 124, Bevacizumab Biosimilar CT-P16, Bevacizumab Biosimilar FKB238, Bevacizumab Biosimilar GB-222, Bevacizumab Biosimilar HD204, Bevacizumab Biosimilar HLX04, Bevacizumab Biosimilar IBI305, Bevacizumab Biosimilar LY01008, Bevacizumab Biosimilar MB02, Bevacizumab Biosimilar MIL60, Bevacizumab Biosimilar Mvasi, Bevacizumab Biosimilar MYL-1402O, Bevacizumab Biosimilar QL 1101, Bevacizumab Biosimilar QL1101, Bevacizumab Biosimilar RPH-001, Bevacizumab Biosimilar SCT501, Bevacizumab Biosimilar Zirabev, Bevacizumab-adcd, Bevacizumab-aveg, Bevacizumab-awwb, Bevacizumab-aybi, Bevacizumab-bvzr, Bevacizumab-byva, Bevacizumab-equi, Bevacizumab-maly, Bevacizumab-nwgd, Bevacizumab-onbe, Bevacizumab-tnjn, BP102, BP102 Biosimilar, Byvasda, CT P16, CT-P16, CTP16, Equidacent, FKB 238, FKB-238, FKB238, HD204, IBI 305, IBI-305, IBI305, Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer, Jobevne, MB 02, MB-02, MB02, Mvasi, MYL-1402O, Onbevzi, Oyavas, PF 06439535, PF-06439535, PF06439535, QL1101, Recombinant Humanized Anti-VEGF Monoclonal Antibody, rhuMab-VEGF, SCT501, SIBP 04, SIBP-04, SIBP04, Vegzelma, Zirabev
DrugCisplatin
Given IV
Also known as: Abiplatin, Blastolem, Briplatin, CDDP, Cis-diammine-dichloroplatinum, Cis-diamminedichloridoplatinum, Cis-diamminedichloro Platinum (II), Cis-diamminedichloroplatinum, Cis-dichloroammine Platinum (II), Cis-platinous Diamine Dichloride, Cis-platinum, Cis-platinum II, Cis-platinum II Diamine Dichloride, Cismaplat, Cisplatina, Cisplatinum, Cisplatyl, Citoplatino, Citosin, Cysplatyna, DDP, Lederplatin, Metaplatin, Neoplatin, Peyrone's Chloride, Peyrone's Salt, Placis, Plastistil, Platamine, Platiblastin, Platiblastin-S, Platinex, Platinol, Platinol- AQ, Platinol-AQ, Platinol-AQ VHA Plus, Platinoxan, Platinum, Platinum Diamminodichloride, Platiran, Platistin, Platosin
DrugDocetaxel
Given IV
Also known as: Docecad, RP 56976, RP-56976, RP56976, Taxotere, Taxotere Injection Concentrate
DrugEtoposide
Given IV
Also known as: Demethyl Epipodophyllotoxin Ethylidine Glucoside, EPEG, Lastet, Toposar, Vepesid, VP 16, VP 16-213, VP 16213, VP-16, VP-16-213, VP-16213, VP16, VP16213
BiologicalFilgrastim
Given SC
Also known as: Filgrastim Biosimilar Filgrastim-sndz, Filgrastim Biosimilar Tbo-filgrastim, Filgrastim XM02, Filgrastim-aafi, Filgrastim-ayow, Filgrastim-sndz, G-CSF, Granix, Neupogen, Neutroval, Nivestim, Nivestym, r-metHuG-CSF, Recombinant Methionyl Human Granulocyte Colony Stimulating Factor, Releuko, rG-CSF, Tbo-filgrastim, Tevagrastim, XM02, Zarxio
BiologicalPegfilgrastim
Given SC
Also known as: Cegfila, Dulastin, Dyrupeg, Filgrastim SD-01, filgrastim-SD/01, Fulphila, Fylnetra, G-Lasta, Grasustek, HSP-130, Jinyouli, Neulasta, Neulastim, Neupopeg, Nyvepria, PEG-filgrastim, Pegcyte, Pegfilgrastim Biosimilar HSP-130, Pegfilgrastim Biosimilar Nyvepria, Pegfilgrastim Biosimilar Pegcyte, Pegfilgrastim Biosimilar PF-06881894, Pegfilgrastim Biosimilar Udenyca, Pegfilgrastim Biosimilar Ziextenzo, Pegfilgrastim-apgf, Pegfilgrastim-bmez, Pegfilgrastim-cbqv, Pegfilgrastim-cegf, Pegfilgrastim-dyru, Pegfilgrastim-fpgk, Pegfilgrastim-gras, Pegfilgrastim-jmdb, Pegfilgrastim-pbbk, Pegfilgrastim-pelg, Pegfilgrastim-pelm, Pegylated G-CSF, Pegylated GCSF, Pegylated Granulocyte Colony Stimulating Factor, Pelgraz, Pelmeg, PF-06881894, SD-01, SD-01 sustained duration G-CSF, Stimufend, Tripegfilgrastim, Udenyca, Ziextenzo
RadiationRadiation Therapy
Undergo thoracic radiotherapy
Also known as: Cancer Radiotherapy, Energy Type, ENERGY_TYPE, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation

What researchers measure

Primary outcomes

Adverse Events
Only adverse events that are possibly, probably or definitely related to study drug are reported.
Time frame: Up to one year

Secondary outcomes

Progression-free Survival
From date of registration to time of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.
Time frame: Disease assessments were performed every 10 weeks as long as the patient remained on protocol treatment, up to 4 years.
Overall Survival
From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
Time frame: Every week, up to 4 years
Response Rate (Confirmed or Unconfirmed Partial Response)
Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions.
Time frame: Response assessment occured at the end of CRT and docetaxel/bevacizumab and then every 2-3 months for 2 years and then every 6 months until 4 years after the initial registration

Results

Posted Feb 29, 2016

Participant flow

Participant flow — Overall Study
Milestone	Low Risk Patient Stratum	High Risk Patient Stratum
Started	16	13
Completed	9	3
Not completed	7	10
Withdrew: Adverse event	3	2
Withdrew: Death	0	2
Withdrew: Progression	1	0
Withdrew: Ineligible	1	1
Withdrew: Patient refused treatment	0	1
Withdrew: Physician decision	2	4

Outcome measures

PrimaryAdverse Events

Only adverse events that are possibly, probably or definitely related to study drug are reported.

Time frame:: Up to one year
Reported as:: Number · Participants

Adverse Events
Participants	Concurrent Chemotherapy and Radiotherapy	Consolidation Therapy With Docetaxel and Bevacizumab.
Acidosis (metabolic or respiratory)	0	1
Arthritis (non-septic)	0	1
Calcium, serum-low (hypocalcemia)	0	1
Carbon monoxide diffusion capacity (DL(co))	1	0
Creatinine	1	0
Dehydration	1	0
Dyspnea (shortness of breath)	1	1
Esophagitis	2	0
FEV(1)	1	0
Febrile neutropenia	3	0
Glucose, serum-high (hyperglycemia)	1	0
Hemoglobin	2	2
Hemorrhage, Respiratory tract NOS	0	1
Hemorrhage, GI - Peritoneal cavity	0	1
Hemorrhage, pulmonary/upper respiratory - Lung	0	1
Hypotension	1	0
Hypoxia	0	1
INR (of prothrombin time)	1	0
Inf (clin/microbio) w/Gr 3-4 neuts - Nose	1	0
Inf (clin/microbio) w/Gr 3-4 neuts - Oral cav-gums	1	0
Inf (clin/microbio) w/Gr 3-4 neuts - UTI	1	0
Inf (clin/microbio) w/Gr 3-4 neuts - Upper airway	0	1
Inf w/normal ANC or Gr 1-2 neutrophils - Blood	1	0
Inf w/normal ANC or Gr 1-2 neutrophils - Lung	1	0
Leukocytes (total WBC)	6	0
Lymphopenia	2	3
Muscle weakness, not d/t neuropathy - body/general	1	1
Nausea	2	0
Neutrophils/granulocytes (ANC/AGC)	10	0
Pain - Chest wall	1	0
Pain - Chest/thorax NOS	1	0
Pain - Head/headache	1	0
Pain - Joint	0	1
Pain - Neck	1	0
Pain - Throat/pharynx/larynx	1	0
Platelets	2	0
Pneumonitis/pulmonary infiltrates	1	2
Potassium, serum-low (hypokalemia)	3	1
Pulmonary/Upper Respiratory-Other (Specify)	0	1
Rash/desquamation	1	0
Rash: dermatitis associated w/radiation	1	0
Sodium, serum-low (hyponatremia)	1	0
Weight loss	0	1

SecondaryProgression-free Survival

From date of registration to time of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.

Time frame:: Disease assessments were performed every 10 weeks as long as the patient remained on protocol treatment, up to 4 years.
Reported as:: Median · Months

Progression-free Survival
Months	Low Risk Patient Stratum	High Risk Patient Stratum
Progression-free Survival	38 (23 to 46)	15 (5 to 17)

SecondaryOverall Survival

From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.

Time frame:: Every week, up to 4 years
Reported as:: Median · Months

Overall Survival
Months	Low Risk Patient Stratum	High Risk Patient Stratum
Overall Survival	46 (26 to 51)	17 (5 to 18)

SecondaryResponse Rate (Confirmed or Unconfirmed Partial Response)

Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions.

Time frame:: Response assessment occured at the end of CRT and docetaxel/bevacizumab and then every 2-3 months for 2 years and then every 6 months until 4 years after the initial registration
Reported as:: Number · percentage of participants

Response Rate (Confirmed or Unconfirmed Partial Response)
percentage of participants	Low Risk Patient Stratum	High Risk Patient Stratum
Response Rate (Confirmed or Unconfirmed Partial Response)	64 (35 to 87)	70 (35 to 93)

Adverse events

Collected over Up to one year.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Concurrent Chemotherapy and Radiotherapy	—	0/26 (0%)	26/26 (100%)
Consolidation Therapy With Docetaxel and Bevacizumab	—	3/21 (14.3%)	17/21 (81%)

Most frequent serious events

Most frequent serious events
Event	Concurrent Chemotherapy and Radiotherapy	Consolidation Therapy With Docetaxel and Bevacizumab
HemoglobinBlood and lymphatic system disorders	0/26	1/21
Hemorrhage, GI - Peritoneal cavityGastrointestinal disorders	0/26	1/21
Thrombosis/embolism (vascular access-related)Injury, poisoning and procedural complications	0/26	1/21
Dyspnea (shortness of breath)Respiratory, thoracic and mediastinal disorders	0/26	1/21
Hemorrhage, Respiratory tract NOSRespiratory, thoracic and mediastinal disorders	0/26	1/21
Hemorrhage, pulmonary/upper respiratory - LungRespiratory, thoracic and mediastinal disorders	0/26	1/21
HypoxiaRespiratory, thoracic and mediastinal disorders	0/26	1/21
Pneumonitis/pulmonary infiltratesRespiratory, thoracic and mediastinal disorders	0/26	1/21
Pulmonary/Upper Respiratory-OtherRespiratory, thoracic and mediastinal disorders	0/26	1/21

Most frequent other events

Showing 10 of 64

Most frequent other events
Event	Concurrent Chemotherapy and Radiotherapy	Consolidation Therapy With Docetaxel and Bevacizumab
Fatigue (asthenia, lethargy, malaise)General disorders	21/26	10/21
NauseaGastrointestinal disorders	17/26	4/21
Neutrophils/granulocytes (ANC/AGC)Investigations	14/26	0/21
EsophagitisGastrointestinal disorders	12/26	2/21
CoughRespiratory, thoracic and mediastinal disorders	9/26	9/21
Hair loss/Alopecia (scalp or body)Skin and subcutaneous tissue disorders	11/26	4/21
Dysphagia (difficulty swallowing)Gastrointestinal disorders	10/26	1/21
PlateletsInvestigations	10/26	5/21
HemoglobinBlood and lymphatic system disorders	9/26	8/21
VomitingGastrointestinal disorders	9/26	3/21

Baseline characteristics

All eligible patients who received protocol treatment.

Age, Continuous
Age, Continuous(years)	Low Risk Patient Stratum	High Risk Patient Stratum	Total
Median	54.5 (32.4 to 70.3)	63.4 (51.1 to 77.2)	60.5 (32.4 to 77.2)

Sex: Female, Male
Sex: Female, Male(Participants)	Low Risk Patient Stratum	High Risk Patient Stratum	Total
Female	9	4	13
Male	6	7	13

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Low Risk Patient Stratum	High Risk Patient Stratum	Total
Hispanic or Latino	0	0	0
Not Hispanic or Latino	13	11	24
Unknown or Not Reported	2	0	2

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Low Risk Patient Stratum	High Risk Patient Stratum	Total
American Indian or Alaska Native	0	0	0
Asian	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	1	2	3
White	14	9	23
More than one race	0	0	0
Unknown or Not Reported	0	0	0

Region of Enrollment
Region of Enrollment(participants)	Low Risk Patient Stratum	High Risk Patient Stratum	Total
United States	15	11	26

Study locations

61 sites

Providence Hospital
Mobile, Alabama 36608, United States
Saint Bernards Regional Medical Center
Jonesboro, Arkansas 72401, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205, United States
Highlands Oncology Group - Rogers
Rogers, Arkansas 72758, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California 90033, United States
Fremont - Rideout Cancer Center
Marysville, California 95901, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California 92868, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California 95817, United States
Providence Santa Rosa Memorial Hospital
Santa Rosa, California 95405, United States
Gene Upshaw Memorial Tahoe Forest Cancer Center
Truckee, California 96161, United States
Northbay Cancer Center
Vacaville, California 95687, United States
Rocky Mountain Regional VA Medical Center
Aurora, Colorado 80045, United States
UCHealth University of Colorado Hospital
Aurora, Colorado 80045, United States
Denver Health Medical Center
Denver, Colorado 80204, United States
Shaw Cancer Center
Edwards, Colorado 81632, United States
Valley View Hospital Cancer Center
Glenwood Springs, Colorado 81601, United States
Montrose Memorial Hospital
Montrose, Colorado 81401, United States
Cancer Centers of Central Florida PA
Leesburg, Florida 34788, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia 31405, United States
Loyola University Medical Center
Maywood, Illinois 60153, United States
Edward Hospital/Cancer Center
Naperville, Illinois 60540, United States
HaysMed
Hays, Kansas 67601, United States
Hutchinson Regional Medical Center
Hutchinson, Kansas 67502, United States
University of Kansas Cancer Center
Kansas City, Kansas 66160, United States
Olathe Cancer Center
Olathe, Kansas 66061, United States
Salina Regional Health Center
Salina, Kansas 67401, United States
University of Kansas Health System Saint Francis Campus
Topeka, Kansas 66606, United States
LSU Health Sciences Center at Shreveport
Shreveport, Louisiana 71103, United States
Highland Clinic
Shreveport, Louisiana 71105, United States
Dana-Farber Cancer Institute at Boston Medical Center - Brighton
Brighton, Massachusetts 02135, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan 48201, United States
McLaren Cancer Institute-Macomb
Mount Clemens, Michigan 48043, United States
University of Mississippi Medical Center
Jackson, Mississippi 39216, United States
Kansas City Veterans Affairs Medical Center
Kansas City, Missouri 64128, United States
Montana Cancer Consortium NCORP
Billings, Montana 59102, United States
Benefis Sletten Cancer Institute
Great Falls, Montana 59405, United States
Arnot Ogden Medical Center/Falck Cancer Center
Elmira, New York 14905, United States
Highland Hospital
Rochester, New York 14620, United States
University of Rochester
Rochester, New York 14642, United States
Novant Health Presbyterian Medical Center
Charlotte, North Carolina 28204, United States
Southeast Clinical Oncology Research Consortium NCORP
Winston-Salem, North Carolina 27104, United States
Oregon Health and Science University
Portland, Oregon 97239, United States
Portland VA Medical Center
Portland, Oregon 97239, United States
Roper Hospital
Charleston, South Carolina 29401, United States
Wellmont Holston Valley Hospital and Medical Center
Kingsport, Tennessee 37660, United States
University of Tennessee Health Science Center
Memphis, Tennessee 38163, United States
The Don and Sybil Harrington Cancer Center
Amarillo, Texas 79106, United States
UT MD Anderson Cancer Center
Houston, Texas 77030, United States
Audie L Murphy VA Hospital
San Antonio, Texas 78229, United States
University Hospital
San Antonio, Texas 78229, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas 78229, United States
Danville Regional Medical Center
Danville, Virginia 24541, United States
Ballad Health Cancer Care - Norton
Norton, Virginia 24273, United States
MultiCare Auburn Medical Center
Auburn, Washington 98001, United States
Providence Regional Cancer System-Centralia
Centralia, Washington 98531, United States
Saint Francis Hospital
Federal Way, Washington 98003, United States
Saint Clare Hospital
Lakewood, Washington 98499, United States
Providence - Saint Peter Hospital
Olympia, Washington 98506-5166, United States
MultiCare Good Samaritan Hospital
Puyallup, Washington 98372, United States
MultiCare Allenmore Hospital
Tacoma, Washington 98405, United States
Saint Joseph Medical Center
Tacoma, Washington 98405, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00334815
Lead sponsor: National Cancer Institute (NCI)
Responsible party: Sponsor
First posted: Jun 8, 2006
Start date: Jun 15, 2006
Primary completion: Jul 1, 2014
Completion: Feb 22, 2027 (estimated)
Results posted: Feb 29, 2016
Last update: Aug 26, 2026

Study contacts

Antoinette J Wozniak

principal investigator · SWOG Cancer Research Network

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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