Carboplatin, Paclitaxel, and Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed During Surgery
NCT ID: NCT00003387
Last Updated: 2016-07-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
366 participants
INTERVENTIONAL
1998-07-31
2009-04-30
Brief Summary
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PURPOSE: Randomized phase III trial to compare the effectiveness of carboplatin and paclitaxel followed by radiation therapy and chemotherapy with radiation therapy and chemotherapy alone in treating patients with stage III non-small cell lung cancer that cannot be removed during surgery.
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Detailed Description
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OUTLINE: This is a randomized study. Patients are stratified by measurable vs evaluable disease. Patients are randomized to 1 of 2 treatment arms: Arm I (immediate concurrent chemoradiotherapy): Patients receive IV paclitaxel over 1 hour followed by IV carboplatin over 30 minutes on day 1, and radiation therapy to the chest 5 times a week beginning on day 1. Treatment repeats weekly for a total of 7 courses. Arm II (induction chemotherapy followed by delayed concurrent chemoradiotherapy): Patients receive IV paclitaxel over 3 hours followed by IV carboplatin over 30 minutes; treatment repeats every 3 weeks for 2 courses. Patients then receive 7 courses of concurrent chemoradiotherapy as in Arm I. Total treatment time is 13 weeks. Patients are followed every 2 months for 2 years, then every 4 months for the next 2 years, then annually thereafter.
PROJECTED ACCRUAL: A total of 360 patients will be accrued for this study within 3 years.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Chemo + radiation
carboplatin
chemotherapy
paclitaxel
radiation therapy
Induction chemo + chemo & radiation
carboplatin
chemotherapy
paclitaxel
radiation therapy
Interventions
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carboplatin
chemotherapy
paclitaxel
radiation therapy
Eligibility Criteria
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Inclusion Criteria
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy No other concurrent chemotherapy Endocrine therapy: No concurrent hormones except for steroids administered for adrenal failure or septic shock, or hormones administered for non-disease-related conditions (e.g., insulin for diabetes) Glucocorticosteroids permitted as antiemetics Radiotherapy: No prior radiotherapy Surgery: At least 2 weeks since exploratory thoracotomy
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Everett E. Vokes, MD
Role: STUDY_CHAIR
University of Chicago
Locations
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Veterans Affairs Medical Center - Birmingham
Birmingham, Alabama, United States
University of California San Diego Cancer Center
La Jolla, California, United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, United States
Howard University Cancer Center
Washington D.C., District of Columbia, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States
University of Illinois at Chicago Health Sciences Center
Chicago, Illinois, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Hematology Oncology Associates of the Quad Cities
Bettendorf, Iowa, United States
Holden Comprehensive Cancer Center at The University of Iowa
Iowa City, Iowa, United States
Veterans Affairs Medical Center - Togus
Togus, Maine, United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, United States
Barnes-Jewish Hospital
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States
Cooper Cancer Institute
Camden, New Jersey, United States
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
CCOP - North Shore University Hospital
Manhasset, New York, United States
North Shore University Hospital
Manhasset, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
New York Presbyterian Hospital - Cornell Campus
New York, New York, United States
Mount Sinai Medical Center, NY
New York, New York, United States
State University of New York - Upstate Medical University
Syracuse, New York, United States
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States
Veterans Affairs Medical Center - Durham
Durham, North Carolina, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Medical University of South Carolina
Charleston, South Carolina, United States
University of Tennessee, Memphis Cancer Center
Memphis, Tennessee, United States
Veterans Affairs Medical Center - Memphis
Memphis, Tennessee, United States
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, United States
Veterans Affairs Medical Center - Richmond
Richmond, Virginia, United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, United States
Countries
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References
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Stinchcombe TE, Hodgson L, Herndon JE 2nd, Kelley MJ, Cicchetti MG, Ramnath N, Niell HB, Atkins JN, Akerley W, Green MR, Vokes EE; Cancer and Leukemia Group B. Treatment outcomes of different prognostic groups of patients on cancer and leukemia group B trial 39801: induction chemotherapy followed by chemoradiotherapy compared with chemoradiotherapy alone for unresectable stage III non-small cell lung cancer. J Thorac Oncol. 2009 Sep;4(9):1117-25. doi: 10.1097/JTO.0b013e3181b27b33.
Vokes EE, Herndon JE 2nd, Kelley MJ, Cicchetti MG, Ramnath N, Neill H, Atkins JN, Watson DM, Akerley W, Green MR; Cancer and Leukemia Group B. Induction chemotherapy followed by chemoradiotherapy compared with chemoradiotherapy alone for regionally advanced unresectable stage III Non-small-cell lung cancer: Cancer and Leukemia Group B. J Clin Oncol. 2007 May 1;25(13):1698-704. doi: 10.1200/JCO.2006.07.3569. Epub 2007 Apr 2.
Other Identifiers
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CLB-39801
Identifier Type: -
Identifier Source: secondary_id
CDR0000066383
Identifier Type: REGISTRY
Identifier Source: secondary_id
CALGB-39801
Identifier Type: -
Identifier Source: org_study_id
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