Lung Cancer Clinical Trial
Official title:
PHASE III STUDY COMPARING TWO DOSES OF INDUCTION CHEMOTHERAPY FOLLOWED BY ALTERNATION OF CHEMOTHERAPY AND RADIOTHERAPY IN LIMITED SMALL CELL LUNG CANCER
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. Combining more than one chemotherapy drug with radiation therapy may kill more tumor
cells. It is not yet known which treatment regimen is more effective for small cell lung
cancer.
PURPOSE: Randomized phase III trial to study the effectiveness of combination chemotherapy
using two different doses of cyclophosphamide followed by alternating chemotherapy and
radiation therapy in treating patients with 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.
;
Allocation: Randomized, Primary Purpose: Treatment
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