Colorectal Cancer Clinical Trial
Official title:
CHEMOTHERAPY CHOICES IN ADVANCED COLORECTAL CANCER: A RANDOMISED TRIAL COMPARING 2 DURATIONS AND 3 SYSTEMIC CHEMOTHERAPY REGIMENS IN THE PALLIATIVE TREATMENT OF ADVANCED COLORECTAL CANCER
RATIONALE: Palliative chemotherapy may help patients with advanced colorectal cancer live
longer and more comfortably.
PURPOSE: Randomized phase III trial to compare the effectiveness of and quality of life
following three different palliative chemotherapy regimens in treating patients with
advanced metastatic or recurrent colorectal cancer.
OBJECTIVES: I. Compare the survival and quality of life of patients with metastatic or
recurrent colorectal cancer receiving palliative therapy with leucovorin/fluorouracil vs.
continuous-infusion fluorouracil vs. ICI D1694. II. Compare the survival and quality of life
of patients with stable or responding disease after 12 weeks of initial treatment randomized
to receive 12 additional weeks of chemotherapy vs. no further treatment.
OUTLINE: This is a randomized study. Patients are stratified by participating institution.
Patients are randomized to one of three treatment regimens. The first group receives
leucovorin followed by fluorouracil every 14 days for a total of 6 courses. The second group
receives continuous-infusion fluorouracil for 12 weeks. The third group receive ICI D1694
every 21 days for a total of 4 courses. Patients without progressive disease or excessive
toxicity after 12 weeks of treatment are then randomized to receive continuing chemotherapy
in 12 weekly cycles of their assigned chemotherapy or to proceed to observation with no
further therapy, until evidence of disease progression. Patients are followed every 6 weeks.
PROJECTED ACCRUAL: A total of 900 patients will be entered.
;
Allocation: Randomized, Primary Purpose: Treatment
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