NCT00334815Active, not recruitingPhase 2
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 Pilot Trial of Cisplatin/Etoposide/Radiotherapy Followed by Consolidation Docetaxel and the Addition of Bevacizumab (NSC-704865) in Three Cohorts of Patients With Inoperable Locally Advanced Stage III Non-small Cell Lung Cancer
Source: ClinicalTrials.gov · Last updated 26 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 29 (actual)
- First submitted
- 7 Jun 2006
- Start date
- 15 Jun 2006
- Primary completion date
- 1 Jul 2014
- Lead sponsor
- National Cancer Institute (NCI)
- Diseases
- Lung cancer
- NCT number
- NCT00334815
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 29
- From 15 Jun 2006 to the primary completion date, 1 Jul 2014
- 61 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (61)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Don and Sybil Harrington Cancer Center Coordinator of this site? Confirm its status | Amarillo | United States | Unknown status |
| MultiCare Auburn Medical Center Coordinator of this site? Confirm its status | Auburn | United States | Unknown status |
| Rocky Mountain Regional VA Medical Center Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| UCHealth University of Colorado Hospital Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| Montana Cancer Consortium NCORP Coordinator of this site? Confirm its status | Billings | United States | Unknown status |
| Dana-Farber Cancer Institute at Boston Medical Center - Brighton Coordinator of this site? Confirm its status | Brighton | United States | Unknown status |
| Providence Regional Cancer System-Centralia Coordinator of this site? Confirm its status | Centralia | United States | Unknown status |
| Roper Hospital Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| Novant Health Presbyterian Medical Center Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| Danville Regional Medical Center Coordinator of this site? Confirm its status | Danville | United States | Unknown status |
| Denver Health Medical Center Coordinator of this site? Confirm its status | Denver | United States | Unknown status |
| Wayne State University/Karmanos Cancer Institute Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| Shaw Cancer Center Coordinator of this site? Confirm its status | Edwards | United States | Unknown status |
| Arnot Ogden Medical Center/Falck Cancer Center Coordinator of this site? Confirm its status | Elmira | United States | Unknown status |
| Saint Francis Hospital Coordinator of this site? Confirm its status | Federal Way | United States | Unknown status |
| Valley View Hospital Cancer Center Coordinator of this site? Confirm its status | Glenwood Springs | United States | Unknown status |
| Benefis Sletten Cancer Institute Coordinator of this site? Confirm its status | Great Falls | United States | Unknown status |
| HaysMed Coordinator of this site? Confirm its status | Hays | United States | Unknown status |
| UT MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Hutchinson Regional Medical Center Coordinator of this site? Confirm its status | Hutchinson | United States | Unknown status |
| University of Mississippi Medical Center Coordinator of this site? Confirm its status | Jackson | United States | Unknown status |
| Saint Bernards Regional Medical Center Coordinator of this site? Confirm its status | Jonesboro | United States | Unknown status |
| University of Kansas Cancer Center Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| Kansas City Veterans Affairs Medical Center Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| Wellmont Holston Valley Hospital and Medical Center Coordinator of this site? Confirm its status | Kingsport | United States | Unknown status |
| Saint Clare Hospital Coordinator of this site? Confirm its status | Lakewood | United States | Unknown status |
| Cancer Centers of Central Florida PA Coordinator of this site? Confirm its status | Leesburg | United States | Unknown status |
| University of Arkansas for Medical Sciences Coordinator of this site? Confirm its status | Little Rock | United States | Unknown status |
| USC / Norris Comprehensive Cancer Center Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Fremont - Rideout Cancer Center Coordinator of this site? Confirm its status | Marysville | United States | Unknown status |
| Loyola University Medical Center Coordinator of this site? Confirm its status | Maywood | United States | Unknown status |
| University of Tennessee Health Science Center Coordinator of this site? Confirm its status | Memphis | United States | Unknown status |
| Providence Hospital Coordinator of this site? Confirm its status | Mobile | United States | Unknown status |
| Montrose Memorial Hospital Coordinator of this site? Confirm its status | Montrose | United States | Unknown status |
| McLaren Cancer Institute-Macomb Coordinator of this site? Confirm its status | Mount Clemens | United States | Unknown status |
| Edward Hospital/Cancer Center Coordinator of this site? Confirm its status | Naperville | United States | Unknown status |
| Ballad Health Cancer Care - Norton Coordinator of this site? Confirm its status | Norton | United States | Unknown status |
| Olathe Cancer Center Coordinator of this site? Confirm its status | Olathe | United States | Unknown status |
| Providence - Saint Peter Hospital Coordinator of this site? Confirm its status | Olympia | United States | Unknown status |
| UC Irvine Health- Chao Family Comprehensive Cancer Center Coordinator of this site? Confirm its status | Orange | United States | Unknown status |
| Portland VA Medical Center Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Oregon Health and Science University Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| MultiCare Good Samaritan Hospital Coordinator of this site? Confirm its status | Puyallup | United States | Unknown status |
| University of Rochester Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Highland Hospital Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Highlands Oncology Group - Rogers Coordinator of this site? Confirm its status | Rogers | United States | Unknown status |
| University of California Davis Comprehensive Cancer Center Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| Salina Regional Health Center Coordinator of this site? Confirm its status | Salina | United States | Unknown status |
| University of Texas Health Science Center at San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| University Hospital Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Audie L Murphy VA Hospital Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Providence Santa Rosa Memorial Hospital Coordinator of this site? Confirm its status | Santa Rosa | United States | Unknown status |
| Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Coordinator of this site? Confirm its status | Savannah | United States | Unknown status |
| LSU Health Sciences Center at Shreveport Coordinator of this site? Confirm its status | Shreveport | United States | Unknown status |
| Highland Clinic Coordinator of this site? Confirm its status | Shreveport | United States | Unknown status |
| MultiCare Allenmore Hospital Coordinator of this site? Confirm its status | Tacoma | United States | Unknown status |
| Saint Joseph Medical Center Coordinator of this site? Confirm its status | Tacoma | United States | Unknown status |
| University of Kansas Health System Saint Francis Campus Coordinator of this site? Confirm its status | Topeka | United States | Unknown status |
| Gene Upshaw Memorial Tahoe Forest Cancer Center Coordinator of this site? Confirm its status | Truckee | United States | Unknown status |
| Northbay Cancer Center Coordinator of this site? Confirm its status | Vacaville | United States | Unknown status |
| Southeast Clinical Oncology Research Consortium NCORP Coordinator of this site? Confirm its status | Winston-Salem | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.