PHASE III STUDY COMPARING TWO DOSES OF INDUCTION CHEMOTHERAPY FOLLOWED BY ALTERNATION OF CHEMOTHERAPY AND RADIOTHERAPY IN LIMITED SMALL CELL LUNG CANCER
N/A
69 Years
Both
Lung Cancer
Trial Information
PHASE III STUDY COMPARING TWO DOSES OF INDUCTION CHEMOTHERAPY FOLLOWED BY ALTERNATION OF CHEMOTHERAPY AND RADIOTHERAPY IN LIMITED SMALL CELL LUNG CANCER
OBJECTIVES: I. Compare the effect on 2-year disease-free survival of two different doses of
cyclophosphamide as part of first induction chemotherapy followed by alternating
chemotherapy and chest irradiation in patients with limited stage small cell lung cancer.
OUTLINE: This is a randomized study. Patients are stratified by participating institution.
All patients receive 2 courses of induction chemotherapy with doxorubicin, etoposide,
cisplatin, and cyclophosphamide. For the first course, one group of patients receives a
lower dose of cyclophosphamide than the other group. Both groups receive the same, and still
lower, dose of cyclophosphamide during the second course. Beginning 1 week after the
completion of induction therapy, patients receive 3 alternating courses each of radiotherapy
to the mediastinal and supraclavicular areas delivered over 10-12 days and chemotherapy as
in the second course of induction. Each course is initiated after a 1-week rest. Patients
receive a final chemotherapy course beginning 4 weeks after the previous chemotherapy
course. Patients are followed every 6 months for survival.
PROJECTED ACCRUAL: A total of 280 patients will be entered.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically proven small cell lung cancer with no distant
metastases Size of initial lesion suitable for total irradiation Positive subclavicular
nodes allowed No malignant pleural effusion No extension into contralateral lung
PATIENT CHARACTERISTICS: Age: Under 70 Performance status: Karnofsky 60%-100%
Hematopoietic: WBC greater than 2,000 Platelets greater than 125,000 Hepatic: Not
specified Renal: Creatinine less than 1.1 mg/dL (100 micromoles/L) Cardiovascular: No
myocardial infarction within 6 months No other cardiovascular disease that precludes
protocol treatment Other: No hearing loss No prior or concurrent malignancy except: Basal
cell skin carcinoma In situ carcinoma of the cervix Accessible for follow-up
PRIOR CONCURRENT THERAPY: No prior chemotherapy, radiotherapy, or surgery
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
Thierry L. Le Chevalier, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Gustave Roussy, Cancer Campus, Grand Paris
Authority:
United States: Federal Government
Study ID:
CDR0000065122
NCT ID:
NCT00002858
Start Date:
March 1993
Completion Date:
Related Keywords:
- Lung Cancer
- limited stage small cell lung cancer
- Lung Neoplasms
- Small Cell Lung Carcinoma
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