The effect of adjuvant treatment with 5-fluorouracil, folinic acid and irinotecan versus 5-fluorouracil and folinic acid only, on disease free survival in Dukes B2 and C colon cancer. A multicenter phase III trial

Hellenic Cooperative Oncology Group0 个研究点目标入组 870 人开始时间: 2010年2月12日最近更新: 2020年1月13日

适应症

试验速览

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•Histologic proof of adenocarcinoma of the colon in who complete resection of the primary tumor has been performed with neither gross nor microscopic evidence of residual disease.
•Dukes stage B or C disease.
•The patient should be randomized into the study between 3 and 6 weeks postoperatively.
•The patient must be willing and able to give informed consent according to the dispositions of the Helsinki convention and its Tokyo and Venice amendments.
•The patient must be maintaining oral nutrition and must be ambulatory at least 50% of the day.

•White Blood Cells (WBC) less than 3,500/mm3 or platelets < 100,000mm3
•Any concurrent second malignant disease or any previous malignant tumor within the previous 3 years except superficial squamous cell or basal cell carcinoma of the skin or in situ carcinoma of the cervix.
•Evidence of unresected distant or regional metastasis
•Pregnant or lactating women
•Ambulatory less than 50% of the day.
•Current history of chronic diarrhea
•Other serious illness

发起方

Hellenic Cooperative Oncology Group