Adjuvant Chemotherapy Clinical Trial
Official title:
Efficacy of Postoperative Adjuvant Chemotherapy for Stage II Colon Cancer With High Risk Factors(EPAC1)
The purpose of this study is to design a prospective randomized clinical trial to explore whether postoperative adjuvant chemotherapy may provide survival benefit for stage II colon cancer patients with high risk factors.Therefore the investigators can provide high level clinical evidence of indications for patients with colon cancer with stage II colon cancer.
The most controversial of adjuvant chemotherapy for colon cancer is whether stage II colon
cancer should receive adjuvant chemotherapy or not. Because of the absolute little benefit of
adjuvant chemotherapy after curative resection of stage II colon cancer，NCCN and ESMO
guidelines do not recommend routine adjuvant chemotherapy for patients with stage II colon
cancer unless combined with high risk factors.
Currently，most studies about stage II colon cancer with high risk factors were retrospective.
Some suggested that patients with stage II colon cancer can benefit from adjuvant
chemotherapy, however, more got the negative conclusions.
The study was designed as a multicenter, prospective, randomized, controlled trial.Patients
who agreed to participate in the study would be randomly assigned to a treatment group of
adjuvant chemotherapy or observation with 50% chance by a central randomization system
determined by the computer program.
After a follow up of at least 3 years, the disease free survival of the two groups will be
compared.
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