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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

Full criteria on ClinicalTrials.gov

Sites (61)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
The Don and Sybil Harrington Cancer Center
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AmarilloUnited StatesUnknown status
MultiCare Auburn Medical Center
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AuburnUnited StatesUnknown status
Rocky Mountain Regional VA Medical Center
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AuroraUnited StatesUnknown status
UCHealth University of Colorado Hospital
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AuroraUnited StatesUnknown status
Montana Cancer Consortium NCORP
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BillingsUnited StatesUnknown status
Dana-Farber Cancer Institute at Boston Medical Center - Brighton
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BrightonUnited StatesUnknown status
Providence Regional Cancer System-Centralia
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CentraliaUnited StatesUnknown status
Roper Hospital
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CharlestonUnited StatesUnknown status
Novant Health Presbyterian Medical Center
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CharlotteUnited StatesUnknown status
Danville Regional Medical Center
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DanvilleUnited StatesUnknown status
Denver Health Medical Center
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DenverUnited StatesUnknown status
Wayne State University/Karmanos Cancer Institute
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DetroitUnited StatesUnknown status
Shaw Cancer Center
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EdwardsUnited StatesUnknown status
Arnot Ogden Medical Center/Falck Cancer Center
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ElmiraUnited StatesUnknown status
Saint Francis Hospital
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Federal WayUnited StatesUnknown status
Valley View Hospital Cancer Center
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Glenwood SpringsUnited StatesUnknown status
Benefis Sletten Cancer Institute
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Great FallsUnited StatesUnknown status
HaysMed
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HaysUnited StatesUnknown status
UT MD Anderson Cancer Center
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HoustonUnited StatesUnknown status
Hutchinson Regional Medical Center
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HutchinsonUnited StatesUnknown status
University of Mississippi Medical Center
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JacksonUnited StatesUnknown status
Saint Bernards Regional Medical Center
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JonesboroUnited StatesUnknown status
University of Kansas Cancer Center
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Kansas CityUnited StatesUnknown status
Kansas City Veterans Affairs Medical Center
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Kansas CityUnited StatesUnknown status
Wellmont Holston Valley Hospital and Medical Center
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KingsportUnited StatesUnknown status
Saint Clare Hospital
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LakewoodUnited StatesUnknown status
Cancer Centers of Central Florida PA
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LeesburgUnited StatesUnknown status
University of Arkansas for Medical Sciences
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Little RockUnited StatesUnknown status
USC / Norris Comprehensive Cancer Center
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Los AngelesUnited StatesUnknown status
Fremont - Rideout Cancer Center
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MarysvilleUnited StatesUnknown status
Loyola University Medical Center
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MaywoodUnited StatesUnknown status
University of Tennessee Health Science Center
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MemphisUnited StatesUnknown status
Providence Hospital
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MobileUnited StatesUnknown status
Montrose Memorial Hospital
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MontroseUnited StatesUnknown status
McLaren Cancer Institute-Macomb
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Mount ClemensUnited StatesUnknown status
Edward Hospital/Cancer Center
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NapervilleUnited StatesUnknown status
Ballad Health Cancer Care - Norton
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NortonUnited StatesUnknown status
Olathe Cancer Center
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OlatheUnited StatesUnknown status
Providence - Saint Peter Hospital
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OlympiaUnited StatesUnknown status
UC Irvine Health- Chao Family Comprehensive Cancer Center
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OrangeUnited StatesUnknown status
Portland VA Medical Center
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PortlandUnited StatesUnknown status
Oregon Health and Science University
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PortlandUnited StatesUnknown status
MultiCare Good Samaritan Hospital
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PuyallupUnited StatesUnknown status
University of Rochester
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RochesterUnited StatesUnknown status
Highland Hospital
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RochesterUnited StatesUnknown status
Highlands Oncology Group - Rogers
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RogersUnited StatesUnknown status
University of California Davis Comprehensive Cancer Center
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SacramentoUnited StatesUnknown status
Salina Regional Health Center
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SalinaUnited StatesUnknown status
University of Texas Health Science Center at San Antonio
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San AntonioUnited StatesUnknown status
University Hospital
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San AntonioUnited StatesUnknown status
Audie L Murphy VA Hospital
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San AntonioUnited StatesUnknown status
Providence Santa Rosa Memorial Hospital
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Santa RosaUnited StatesUnknown status
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
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SavannahUnited StatesUnknown status
LSU Health Sciences Center at Shreveport
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ShreveportUnited StatesUnknown status
Highland Clinic
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ShreveportUnited StatesUnknown status
MultiCare Allenmore Hospital
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TacomaUnited StatesUnknown status
Saint Joseph Medical Center
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TacomaUnited StatesUnknown status
University of Kansas Health System Saint Francis Campus
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TopekaUnited StatesUnknown status
Gene Upshaw Memorial Tahoe Forest Cancer Center
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TruckeeUnited StatesUnknown status
Northbay Cancer Center
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VacavilleUnited StatesUnknown status
Southeast Clinical Oncology Research Consortium NCORP
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Winston-SalemUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.