Chemotherapy Plus Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
NCT ID: NCT00003812
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
PHASE2
75 participants
INTERVENTIONAL
1999-03-31
2006-03-31
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus radiation therapy in treating patients who have limited-stage small cell lung cancer.
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Detailed Description
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OUTLINE: Patients receive topotecan IV on days 1-5 and paclitaxel IV over 3 hours on day 1. Filgrastim (G-CSF) is administered subcutaneously every day starting on day 6 until blood counts recover. The course is repeated once beginning on day 22. After restaging, patients begin thoracic radiotherapy daily, five days per week, for 6-7 weeks. On the same day that radiotherapy begins, patients receive carboplatin IV over 1 hour (day 43) and etoposide IV over 1 hour daily for 3 days (days 43-45). The consolidation chemotherapy is repeated every 21 days for a total of 3 courses. Patients with stable or responding disease undergo prophylactic cranial irradiation. Patients are followed at least every 3 months for 2 years, every 6 months for 3 years, and then at least every year.
PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study within 15-18 months.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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chemotherapy + radiation therapy
Patients receive topotecan IV on days 1-5 and paclitaxel IV over 3 hours on day 1. Filgrastim (G-CSF) is administered subcutaneously every day starting on day 6 until blood counts recover. The course is repeated once beginning on day 22. After restaging, patients begin thoracic radiotherapy daily, five days per week, for 6-7 weeks. On the same day that radiotherapy begins, patients receive carboplatin IV over 1 hour (day 43) and etoposide IV over 1 hour daily for 3 days (days 43-45). The consolidation chemotherapy is repeated every 21 days for a total of 3 courses. Patients with stable or responding disease undergo prophylactic cranial irradiation. Patients are followed at least every 3 months for 2 years, every 6 months for 3 years, and then at least every year.
filgrastim
carboplatin
etoposide
paclitaxel
topotecan hydrochloride
radiation therapy
Interventions
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filgrastim
carboplatin
etoposide
paclitaxel
topotecan hydrochloride
radiation therapy
Eligibility Criteria
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Inclusion Criteria
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for small cell lung cancer No other concurrent chemotherapy Endocrine therapy: No concurrent steroids except for adrenal failure No concurrent hormones except for nondisease related conditions (e.g., insulin for diabetes) No concurrent dexamethasone except for intermittent use as an antiemetic or as an adjunct to prophylactic cranial irradiation Radiotherapy: No prior mediastinal radiotherapy Surgery: Not specified
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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Alan P. Lyss, MD
Role: STUDY_CHAIR
Missouri Baptist Cancer Center
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
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, United States
Vincent T. Lombardi Cancer Research Center, Georgetown University
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
University of Iowa Hospitals and Clinics
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
Missouri Baptist Cancer Center
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
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
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, 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
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 of Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Veterans Affairs Medical Center - Memphis
Memphis, Tennessee, United States
University of Tennessee, Memphis Cancer Center
Memphis, Tennessee, United States
Vermont Cancer Center
Burlington, Vermont, 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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Bogart JA, Herndon JE 2nd, Lyss AP, Watson D, Miller AA, Lee ME, Turrisi AT, Green MR; Cancer and Leukemia Group B study 39808. 70 Gy thoracic radiotherapy is feasible concurrent with chemotherapy for limited-stage small-cell lung cancer: analysis of Cancer and Leukemia Group B study 39808. Int J Radiat Oncol Biol Phys. 2004 Jun 1;59(2):460-8. doi: 10.1016/j.ijrobp.2003.10.021.
Cicchetti MG, Bogart J, Lyss A, et al.: Spinal cord dose in limited stage small cell lung cancer: a preliminary Quality Assurance Review Committee (QARC) report on CALGB 39808, using target thoracic radiotherapy (TRT) doses of 60 - 70 Gy. [Abstract] Int J Radiat Oncol Biol Phys 51(3 suppl 1): A-656, 356, 2001.
Lyss AP, Herndon JE, Bogart JE, et al.: Topotecan (Topo) + paclitaxel (Tax) + G-CSF (G) induction followed by concurrent chemoradiotherapy (CCRT) for patients (pts) with limited stage small cell lung cancer (L-SCLC): preliminary analysis of CALGB 39808. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-1270, 2001.
Other Identifiers
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CLB-39808
Identifier Type: -
Identifier Source: secondary_id
CDR0000066958
Identifier Type: REGISTRY
Identifier Source: secondary_id
CALGB-39808
Identifier Type: -
Identifier Source: org_study_id
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