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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

Primary Purpose

Lung Adenocarcinoma, Lung Adenosquamous Carcinoma, Lung Large Cell Carcinoma

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bevacizumab
Cisplatin
Docetaxel
Etoposide
Filgrastim
Pegfilgrastim
Radiation Therapy
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Providence Hospital
  • Saint Bernards Regional Medical Center
  • University of Arkansas for Medical Sciences
  • Highlands Oncology Group - Rogers
  • USC / Norris Comprehensive Cancer Center
  • Fremont - Rideout Cancer Center
  • UC Irvine Health/Chao Family Comprehensive Cancer Center
  • University of California Davis Comprehensive Cancer Center
  • Providence Santa Rosa Memorial Hospital
  • Gene Upshaw Memorial Tahoe Forest Cancer Center
  • Northbay Cancer Center
  • Rocky Mountain Regional VA Medical Center
  • UCHealth University of Colorado Hospital
  • Denver Health Medical Center
  • University of Colorado
  • Shaw Cancer Center
  • Valley View Hospital Cancer Center
  • Montrose Memorial Hospital
  • Cancer Centers of Central Florida PA
  • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
  • Loyola University Medical Center
  • Edward Hospital/Cancer Center
  • HaysMed University of Kansas Health System
  • Hutchinson Regional Medical Center
  • University of Kansas Cancer Center
  • Olathe Cancer Center
  • Salina Regional Health Center
  • University of Kansas Health System Saint Francis Campus
  • LSU Health Sciences Center at Shreveport
  • Highland Clinic
  • Steward Saint Elizabeth's Medical Center
  • Wayne State University/Karmanos Cancer Institute
  • McLaren Cancer Institute-Macomb
  • University of Mississippi Medical Center
  • Kansas City Veterans Affairs Medical Center
  • Montana Cancer Consortium NCORP
  • Benefis Healthcare- Sletten Cancer Institute
  • Arnot Ogden Medical Center/Falck Cancer Center
  • Highland Hospital
  • University of Rochester
  • Novant Health Presbyterian Medical Center
  • Southeast Clinical Oncology Research Consortium NCORP
  • Oregon Health and Science University
  • Portland VA Medical Center
  • Roper Hospital
  • Wellmont Holston Valley Hospital and Medical Center
  • University of Tennessee Health Science Center
  • The Don and Sybil Harrington Cancer Center
  • M D Anderson Cancer Center
  • Audie L Murphy VA Hospital
  • Cancer Therapy and Research Center at The UT Health Science Center at San Antonio
  • University Hospital
  • University of Texas Health Science Center at San Antonio
  • Danville Regional Medical Center
  • Southwest VA Regional Cancer Center
  • MultiCare Auburn Medical Center
  • Providence Regional Cancer System-Centralia
  • Saint Francis Hospital
  • Saint Clare Hospital
  • Providence - Saint Peter Hospital
  • MultiCare Good Samaritan Hospital
  • MultiCare Allenmore Hospital
  • Saint Joseph Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group 1 (cisplatin, etoposide, radiotherapy)

Group 2 (cisplatin, etoposide, radiotherapy, bevacizumab)

Group 3 (cisplatin, etoposide, radiotherapy, bevacizumab)

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
June 7, 2006
Last Updated
September 12, 2023
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00334815
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 15, 2006 (Actual)
Primary Completion Date
July 1, 2014 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 (cisplatin, etoposide, radiotherapy)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 2 (cisplatin, etoposide, radiotherapy, bevacizumab)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 3 (cisplatin, etoposide, radiotherapy, bevacizumab)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
ABP 215, Anti-VEGF, Anti-VEGF Humanized Monoclonal Antibody, Anti-VEGF Monoclonal Antibody SIBP04, Anti-VEGF rhuMAb, Avastin, 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 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-awwb, Bevacizumab-bvzr, BP102, BP102 Biosimilar, CT-P16, HD204, 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, Mvasi, MYL-1402O, QL1101, Recombinant Humanized Anti-VEGF Monoclonal Antibody, rhuMab-VEGF, SCT501, SIBP 04, SIBP-04, SIBP04, Vegzelma, Zirabev
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
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
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Docecad, RP 56976, RP56976, Taxotere, Taxotere Injection Concentrate
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
Etoposide
Other Intervention Name(s)
Demethyl Epipodophyllotoxin Ethylidine Glucoside, EPEG, Lastet, Toposar, Vepesid, VP 16, VP 16-213, VP 16213, VP-16, VP-16-213, VP16
Intervention Description
Given IV
Intervention Type
Biological
Intervention Name(s)
Filgrastim
Other Intervention Name(s)
Filgrastim Biosimilar Filgrastim-sndz, Filgrastim Biosimilar Tbo-filgrastim, Filgrastim XM02, Filgrastim-aafi, Filgrastim-ayow, Filgrastim-sndz, G-CSF, Granix, Neupogen, Neutroval, Nivestym, r-metHuG-CSF, Recombinant Methionyl Human Granulocyte Colony Stimulating Factor, Releuko, rG-CSF, Tbo-filgrastim, Tevagrastim, XM02, Zarxio
Intervention Description
Given SC
Intervention Type
Biological
Intervention Name(s)
Pegfilgrastim
Other Intervention Name(s)
Filgrastim SD-01, filgrastim-SD/01, Fulphila, 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-jmdb, Pegylated G-CSF, Pegylated GCSF, Pegylated Granulocyte Colony Stimulating Factor, PF-06881894, SD-01, SD-01 sustained duration G-CSF, Udenyca, Ziextenzo
Intervention Description
Given SC
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy
Other Intervention Name(s)
Cancer Radiotherapy, Energy Type, ENERGY_TYPE, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation
Intervention Description
Undergo thoracic radiotherapy
Primary Outcome Measure Information:
Title
Adverse Events
Description
Only adverse events that are possibly, probably or definitely related to study drug are reported.
Time Frame
Up to one year
Secondary Outcome Measure Information:
Title
Progression-free Survival
Description
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.
Title
Overall Survival
Description
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
Title
Response Rate (Confirmed or Unconfirmed Partial Response)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoinette J Wozniak
Organizational Affiliation
SWOG Cancer Research Network
Official's Role
Principal Investigator
Facility Information:
Facility Name
Providence Hospital
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Saint Bernards Regional Medical Center
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Highlands Oncology Group - Rogers
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Facility Name
USC / Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Fremont - Rideout Cancer Center
City
Marysville
State/Province
California
ZIP/Postal Code
95901
Country
United States
Facility Name
UC Irvine Health/Chao Family Comprehensive Cancer Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
University of California Davis Comprehensive Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Providence Santa Rosa Memorial Hospital
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95405
Country
United States
Facility Name
Gene Upshaw Memorial Tahoe Forest Cancer Center
City
Truckee
State/Province
California
ZIP/Postal Code
96161
Country
United States
Facility Name
Northbay Cancer Center
City
Vacaville
State/Province
California
ZIP/Postal Code
95687
Country
United States
Facility Name
Rocky Mountain Regional VA Medical Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
UCHealth University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Denver Health Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
University of Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80217-3364
Country
United States
Facility Name
Shaw Cancer Center
City
Edwards
State/Province
Colorado
ZIP/Postal Code
81632
Country
United States
Facility Name
Valley View Hospital Cancer Center
City
Glenwood Springs
State/Province
Colorado
ZIP/Postal Code
81601
Country
United States
Facility Name
Montrose Memorial Hospital
City
Montrose
State/Province
Colorado
ZIP/Postal Code
81401
Country
United States
Facility Name
Cancer Centers of Central Florida PA
City
Leesburg
State/Province
Florida
ZIP/Postal Code
34788
Country
United States
Facility Name
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Edward Hospital/Cancer Center
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60540
Country
United States
Facility Name
HaysMed University of Kansas Health System
City
Hays
State/Province
Kansas
ZIP/Postal Code
67601
Country
United States
Facility Name
Hutchinson Regional Medical Center
City
Hutchinson
State/Province
Kansas
ZIP/Postal Code
67502
Country
United States
Facility Name
University of Kansas Cancer Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Olathe Cancer Center
City
Olathe
State/Province
Kansas
ZIP/Postal Code
66061
Country
United States
Facility Name
Salina Regional Health Center
City
Salina
State/Province
Kansas
ZIP/Postal Code
67401
Country
United States
Facility Name
University of Kansas Health System Saint Francis Campus
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
LSU Health Sciences Center at Shreveport
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Highland Clinic
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105
Country
United States
Facility Name
Steward Saint Elizabeth's Medical Center
City
Brighton
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
Wayne State University/Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
McLaren Cancer Institute-Macomb
City
Mount Clemens
State/Province
Michigan
ZIP/Postal Code
48043
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Kansas City Veterans Affairs Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64128
Country
United States
Facility Name
Montana Cancer Consortium NCORP
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Facility Name
Benefis Healthcare- Sletten Cancer Institute
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Arnot Ogden Medical Center/Falck Cancer Center
City
Elmira
State/Province
New York
ZIP/Postal Code
14905
Country
United States
Facility Name
Highland Hospital
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Novant Health Presbyterian Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Southeast Clinical Oncology Research Consortium NCORP
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27104
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Portland VA Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Roper Hospital
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401
Country
United States
Facility Name
Wellmont Holston Valley Hospital and Medical Center
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
University of Tennessee Health Science Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States
Facility Name
The Don and Sybil Harrington Cancer Center
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Audie L Murphy VA Hospital
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Cancer Therapy and Research Center at The UT Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
University Hospital
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Danville Regional Medical Center
City
Danville
State/Province
Virginia
ZIP/Postal Code
24541
Country
United States
Facility Name
Southwest VA Regional Cancer Center
City
Norton
State/Province
Virginia
ZIP/Postal Code
24273
Country
United States
Facility Name
MultiCare Auburn Medical Center
City
Auburn
State/Province
Washington
ZIP/Postal Code
98001
Country
United States
Facility Name
Providence Regional Cancer System-Centralia
City
Centralia
State/Province
Washington
ZIP/Postal Code
98531
Country
United States
Facility Name
Saint Francis Hospital
City
Federal Way
State/Province
Washington
ZIP/Postal Code
98003
Country
United States
Facility Name
Saint Clare Hospital
City
Lakewood
State/Province
Washington
ZIP/Postal Code
98499
Country
United States
Facility Name
Providence - Saint Peter Hospital
City
Olympia
State/Province
Washington
ZIP/Postal Code
98506-5166
Country
United States
Facility Name
MultiCare Good Samaritan Hospital
City
Puyallup
State/Province
Washington
ZIP/Postal Code
98372
Country
United States
Facility Name
MultiCare Allenmore Hospital
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Saint Joseph Medical Center
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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