Phase III Intergroup Trial of Irinotecan (CPT-11) (NSC# 616348) Plus Luorouracil/Leucovorin (5-FU/LV) Versus Fluorouracil/Leucovorin Alone After Curative Resection for Patients With Stage III Colon Cancer
I. Compare the overall and disease free survival of patients with stage III colon cancer
treated with adjuvant fluorouracil and leucovorin calcium with or without irinotecan.
II. Assess prognostic markers and correlate their expression with disease free and overall
survival of these patients.
III. Assess the influence of diet, body mass index, and physical activity on the risk of
cancer recurrence and survival in these patients.
IV. Assess the influence of diet, obesity, and physical activity on the risk of toxicity
associated with adjuvant therapy in these patients.
V. Determine whether pathological features (including tumor grade, tumor mitotic
(proliferation) index, tumor border configuration, and host lymphoid response to tumor; and
lymphatic vessel, venous vessel and perineural invasion) predict outcome in this patient
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to lymph
node involvement (1-3 vs 4 or more), histology (poorly differentiated or undifferentiated vs
well or moderately differentiated), and preoperative serum CEA (less than 5.0 ng/mL vs at
least 5.0 ng/mL vs unknown). Study therapy must begin within 21-56 days after surgery.
Patients are randomized to one of two treatment arms:
ARM I: Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV beginning 1
hour into leucovorin calcium infusion weekly for 6 weeks. Treatment is repeated every 8
weeks for 4 courses.
ARM II: Patients receive irinotecan IV over 90 minutes, followed by leucovorin calcium IV,
then followed by fluorouracil IV weekly for 4 weeks. Treatment is repeated every 6 weeks for
Patients complete a food questionnaire at the beginning of the third course and then at 6
months after study therapy.
Patients are followed every 3 months for 2 years, every 4 months for 2 years, then annually
PROJECTED ACCRUAL: A total of 1260 patients will be accrued for this study within 3 years.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to recurrence
The Cox proportional hazards model will be used to determine the association between each marker and time to recurrence and survival controlling for other baseline factors such as age, gender, treatment, primary tumor site, degree of differentiation.
From time of resection until documented disease progression, assessed up to 6 years
Cancer and Leukemia Group B
United States: Food and Drug Administration
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