Combination Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
NCT ID: NCT00004209
Last Updated: 2013-08-07
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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UNKNOWN
PHASE3
INTERVENTIONAL
1998-05-31
Brief Summary
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PURPOSE: Randomized phase III trial to compare the effectiveness of three courses of combination chemotherapy with that of six courses of combination chemotherapy in treating patients who have stage IIIB or stage IV non-small cell lung cancer.
Detailed Description
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OUTLINE: This is a randomized, multicenter study. Patients are stratified by stage of disease (stage IIIB vs IV). Patients are randomized to 1 of 2 treatment arms: Arm I: Patients receive cisplatin IV over 4 hours, mitomycin IV, and vinblastine IV on day 1. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Mitomycin is not administered during course 3. Arm II: Patients receive chemotherapy as in arm I. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Mitomycin is not administered during courses 3 and 5. Quality of life is assessed after completion of 3 courses of chemotherapy for patients in arm I and after completion of 4, 5, and 6 courses for those in arm II. Patients may receive radiotherapy beginning after completion of chemotherapy.
PROJECTED ACCRUAL: A total of 310 patients will be accrued for this study.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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cisplatin
mitomycin C
vinblastine sulfate
Eligibility Criteria
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Inclusion Criteria
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior conventional chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Surgery: See Disease Characteristics
18 Years
ALL
No
Sponsors
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Cancer Research UK
OTHER
Principal Investigators
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Ian E. Smith, MD
Role: STUDY_CHAIR
Royal Marsden NHS Foundation Trust
Locations
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Royal Marsden NHS Trust
London, England, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom
Countries
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Other Identifiers
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CDR0000067457
Identifier Type: REGISTRY
Identifier Source: secondary_id
EU-99017
Identifier Type: -
Identifier Source: secondary_id
ICRF-95.240
Identifier Type: -
Identifier Source: org_study_id