Concurrent Carboplatin, Paclitaxel, and Radiation Therapy Versus Induction Carboplatin and Paclitaxel Followed by Concurrent Carboplatin, Paclitaxel and Radiation Therapy for Patients With Unresectable Stage III Non-Small Cell Lung Cancer: A Phase III Trial
OBJECTIVES: I. Compare the effects of concurrent chemoradiotherapy utilizing carboplatin and
paclitaxel with or without prior induction chemotherapy on overall response rate,
disease-free survival, and overall survival in patients with unresectable stage III
non-small cell lung cancer. II. Compare the effects of these treatments on locoregional vs
distant failure in these patients. III. Compare the toxicity of these treatments in these
patients.
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.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Everett E. Vokes, MD
Study Chair
University of Chicago
United States: Federal Government
CDR0000066383
NCT00003387
July 1998
April 2009
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
Walter Reed Army Medical Center | Washington, District of Columbia 20307-5000 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
University of Massachusetts Memorial Medical Center | Worcester, Massachusetts 01655 |
Lineberger Comprehensive Cancer Center, UNC | Chapel Hill, North Carolina 27599-7295 |
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
Rhode Island Hospital | Providence, Rhode Island 02903 |
CCOP - Southern Nevada Cancer Research Foundation | Las Vegas, Nevada 89106 |
University of California San Diego Cancer Center | La Jolla, California 92093-0658 |
UCSF Cancer Center and Cancer Research Institute | San Francisco, California 94115-0128 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
CCOP - Mount Sinai Medical Center | Miami Beach, Florida 33140 |
Marlene & Stewart Greenebaum Cancer Center, University of Maryland | Baltimore, Maryland 21201 |
Ellis Fischel Cancer Center - Columbia | Columbia, Missouri 65203 |
Barnes-Jewish Hospital | Saint Louis, Missouri 63110 |
Norris Cotton Cancer Center | Lebanon, New Hampshire 03756 |
CCOP - North Shore University Hospital | Manhasset, New York 11030 |
State University of New York - Upstate Medical University | Syracuse, New York 13210 |
CCOP - Southeast Cancer Control Consortium | Winston-Salem, North Carolina 27104-4241 |
University of Tennessee, Memphis Cancer Center | Memphis, Tennessee 38103 |
MBCCOP - Massey Cancer Center | Richmond, Virginia 23298-0037 |
Mount Sinai Medical Center, NY | New York, New York 10029 |
New York Presbyterian Hospital - Cornell Campus | New York, New York 10021 |
Holden Comprehensive Cancer Center at The University of Iowa | Iowa City, Iowa 52242-1009 |
Comprehensive Cancer Center at Wake Forest University | Winston-Salem, North Carolina 27157-1082 |
Veterans Affairs Medical Center - Birmingham | Birmingham, Alabama 35233 |
Veterans Affairs Medical Center - White River Junction | White River Junction, Vermont 05009 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
North Shore University Hospital | Manhasset, New York 11030 |
Veterans Affairs Medical Center - Chicago (Westside Hospital) | Chicago, Illinois 60612 |
Veterans Affairs Medical Center - San Francisco | San Francisco, California 94121 |
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | Syracuse, New York 13217 |
Veterans Affairs Medical Center - Memphis | Memphis, Tennessee 38104 |
Veterans Affairs Medical Center - Richmond | Richmond, Virginia 23249 |
University of Illinois at Chicago Health Sciences Center | Chicago, Illinois 60612 |
Veterans Affairs Medical Center - Togus | Togus, Maine 04330 |
Veterans Affairs Medical Center - Minneapolis | Minneapolis, Minnesota 55417 |
Veterans Affairs Medical Center - Columbia (Truman Memorial) | Columbia, Missouri 65201 |
University of Nebraska Medical Center | Omaha, Nebraska 68198-3330 |
Veterans Affairs Medical Center - Buffalo | Buffalo, New York 14215 |
Veterans Affairs Medical Center - Syracuse | Syracuse, New York 13210 |
Veterans Affairs Medical Center - Durham | Durham, North Carolina 27705 |
Cooper Cancer Institute | Camden, New Jersey 08103 |
Hematology Oncology Associates of the Quad Cities | Bettendorf, Iowa 52722 |
Howard University Cancer Center | Washington, District of Columbia 20060 |