Combination Chemotherapy and Computer-Planned Radiation Therapy in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer
- Conditions
- Lung Cancer
- Interventions
- Registration Number
- NCT00033553
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Computer systems that allow doctors to create a 3-dimensional picture of the tumor to plan treatment may result in more effective radiation therapy. It is not yet known which chemotherapy and/or radiation therapy regimen is more effective in treating non-small cell lung cancer.
PURPOSE: Randomized phase II trial to compare the effectiveness of different combination chemotherapy regimens and 3-dimensional radiation therapy in treating patients who have unresectable stage III non-small cell lung cancer.
- Detailed Description
OBJECTIVES:
* Compare the overall response rate, failure-free survival, and survival of patients with inoperable stage IIIA or IIIB non-small cell lung cancer treated with paclitaxel and carboplatin with concurrent 3-dimensional conformal radiotherapy (3-D XRT) vs gemcitabine and carboplatin with concurrent 3-D XRT.
* Compare the toxicity of these regimens in these patients.
* Compare the pattern of failure (locoregional vs distant failure) in patients treated with these regimens.
* Determine the feasibility of delivering 3-D XRT to patients in this multicenter study.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms.
* Arm I: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses. Patients then receive paclitaxel IV over 1 hour followed by carboplatin IV over 30 minutes once weekly and 3-dimensional conformal radiotherapy (3-D XRT) once daily 5 days a week. Treatment repeats weekly for 7 courses.
* Arm II: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses. Patients then receive gemcitabine IV over 30 minutes twice weekly and 3-D XRT as in arm I. Treatment repeats weekly for 7 courses.
In both arms, treatment continues in the absence of disease progression.
Patients are followed every 2 months for 2 years, every 4 months for 2 years, and then annually for 2 years.
PROJECTED ACCRUAL: A total of 82 patients (41 per treatment arm) will be accrued for this study within 9 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 69
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Paclitaxel + Carboplatin radiation therapy Paclitaxel and carboplatin induction (2 cycles)followed by chemotherapy with the addition of radiotherapy for 7 cycles Gemcitabine + Carboplatin radiation therapy Gemcitabine and carboplatin induction (2cycles) followed by chemotherapy with the addition of radiotherapy for 7 cycles Gemcitabine + Carboplatin gemcitabine hydrochloride Gemcitabine and carboplatin induction (2cycles) followed by chemotherapy with the addition of radiotherapy for 7 cycles Paclitaxel + Carboplatin carboplatin Paclitaxel and carboplatin induction (2 cycles)followed by chemotherapy with the addition of radiotherapy for 7 cycles Paclitaxel + Carboplatin paclitaxel Paclitaxel and carboplatin induction (2 cycles)followed by chemotherapy with the addition of radiotherapy for 7 cycles Gemcitabine + Carboplatin carboplatin Gemcitabine and carboplatin induction (2cycles) followed by chemotherapy with the addition of radiotherapy for 7 cycles
- Primary Outcome Measures
Name Time Method Response 18 months post treatment Response is assessed as failure free survival
- Secondary Outcome Measures
Name Time Method Overall Survival 6 years post treatment Toxicity 13 weeks Toxicity will be assessed during treatment
Trial Locations
- Locations (74)
Lombardi Cancer Center at Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
Veterans Affairs Medical Center - Washington, DC
🇺🇸Washington, District of Columbia, United States
New Hampshire Oncology-Hematology, PA - Hooksett
🇺🇸Hooksett, New Hampshire, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
UMASS Memorial Cancer Center - University Campus
🇺🇸Worcester, Massachusetts, United States
SUNY Upstate Medical University Hospital
🇺🇸Syracuse, New York, United States
Veterans Affairs Medical Center - Syracuse
🇺🇸Syracuse, New York, United States
Veterans Affairs Medical Center - Asheville
🇺🇸Asheville, North Carolina, United States
Fort Wayne Medical Oncology and Hematology, Incorporated
🇺🇸Fort Wayne, Indiana, United States
CCOP - Northern Indiana CR Consortium
🇺🇸South Bend, Indiana, United States
Rebecca and John Moores UCSD Cancer Center
🇺🇸La Jolla, California, United States
Memorial Regional Cancer Center at Memorial Regional Hospital
🇺🇸Hollywood, Florida, United States
Louis A. Weiss Memorial Hospital
🇺🇸Chicago, Illinois, United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
🇺🇸Columbia, Missouri, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Holden Comprehensive Cancer Center at University of Iowa
🇺🇸Iowa City, Iowa, United States
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
🇺🇸Chicago, Illinois, United States
Siteman Cancer Center at Barnes-Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
🇺🇸Columbia, Missouri, United States
CCOP - Christiana Care Health Services
🇺🇸Newark, Delaware, United States
CCOP - Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
CCOP - North Shore University Hospital
🇺🇸Manhasset, New York, United States
Queens Cancer Center of Queens Hospital
🇺🇸Jamaica, New York, United States
Comprehensive Cancer Center at Moore Regional Hospital
🇺🇸Pinehurst, North Carolina, United States
New York Weill Cornell Cancer Center at Cornell University
🇺🇸New York, New York, United States
Mount Sinai Medical Center
🇺🇸New York, New York, United States
Veterans Affairs Medical Center - Buffalo
🇺🇸Buffalo, New York, United States
Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke
🇺🇸Roanoke, Virginia, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
🇺🇸Columbus, Ohio, United States
CCOP - Southeast Cancer Control Consortium
🇺🇸Goldsboro, North Carolina, United States
NorthEast Oncology Associates - Concord
🇺🇸Concord, North Carolina, United States
CCOP - Southern Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
Veterans Affairs Medical Center - Las Vegas
🇺🇸Las Vegas, Nevada, United States
Naval Medical Center - San Diego
🇺🇸San Diego, California, United States
Veterans Affairs Medical Center - Minneapolis
🇺🇸Minneapolis, Minnesota, United States
University of Minnesota Cancer Center
🇺🇸Minneapolis, Minnesota, United States
Veterans Affairs Medical Center - Durham
🇺🇸Durham, North Carolina, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
UCSF Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Veterans Affairs Medical Center - San Francisco
🇺🇸San Francisco, California, United States
Oklahoma University Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
🇺🇸East Syracuse, New York, United States
Lenoir Memorial Cancer Center
🇺🇸Kinston, North Carolina, United States
Veterans Affairs Medical Center - Dallas
🇺🇸Dallas, Texas, United States
Martha Jefferson Hospital
🇺🇸Charlottesville, Virginia, United States
Virginia Oncology Associates - Norfolk
🇺🇸Norfolk, Virginia, United States
Northeast Alabama Regional Medical Center
🇺🇸Anniston, Alabama, United States
Veterans Affairs Medical Center - San Diego
🇺🇸San Diego, California, United States
Broward General Medical Center
🇺🇸Fort Lauderdale, Florida, United States
West Suburban Center for Cancer Care
🇺🇸River Forest, Illinois, United States
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
🇺🇸Saint Joseph, Michigan, United States
Cancer Institute of New Jersey at the Cooper University Hospital
🇺🇸Camden, New Jersey, United States
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Missouri Baptist Cancer Center
🇺🇸Saint Louis, Missouri, United States
Elmhurst Hospital Center
🇺🇸Elmhurst, New York, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
Western Pennsylvania Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Cape Fear Valley Health System
🇺🇸Fayetteville, North Carolina, United States
Lifespan: The Miriam Hospital
🇺🇸Providence, Rhode Island, United States
Vermont Cancer Center at University of Vermont
🇺🇸Burlington, Vermont, United States
St. Mary's Medical Center
🇺🇸Huntington, West Virginia, United States
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
MBCCOP - Massey Cancer Center
🇺🇸Richmond, Virginia, United States
Zimmer Cancer Center at New Hanover Regional Medical Center
🇺🇸Wilmington, North Carolina, United States
Baptist Hospital East - Louisville
🇺🇸Louisville, Kentucky, United States
Florida Hospital Cancer Institute
🇺🇸Orlando, Florida, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States