Neoplasms

Digestive System Diseases

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Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

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Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

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Herbal and Botanical

Capecitabine

Oxaliplatin

Antimetabolites

Cola

patients enrolled int the adjuvant chemotherapy group will receive adjuvant chemotherapy\[CapeOX（Capecitabine+Oxaliplatin）\] by the current guidelines

patients enrolled int the adjuvant chemotherapy group will not receive adjuvant chemotherapy just for observation

Patients enrolled in the chemotherapy group would receive postoperative chemotherapy CapeOX（Capecitabine+Oxaliplatin）for 6 months

CapeOX（Capecitabine+Oxaliplatin）

Patients enrolled in the observation group would not receive any chemotherapy drugs just for observation

Observation

Pengju Chen, M.D.

Aiwen Wu, M.D.

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.

Efficacy of Postoperative Adjuvant Chemotherapy for Stage II Colon Cancer With High Risk Factors(EPAC1)

Disease free survival was defined as the duration after local recurrence or metastasis were found after surgery. Metastasis of any distant organs such as liver, lung, ovary，bone and peritoneum were defined by CT.

Overall survival was defined as the duration from randomization to death from any cause

All the high risk factors enrolled in this study will be analyzed one by one to investigate the relationship between high risk factors and survival.

Toxic reaction in the chemotherapy group.Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Efficacy of Postoperative Adjuvant Chemotherapy for Stage II Colon Cancer With High Risk Factors(EPAC1)	NCT03199989	Adjuvant Chemot...	CapeOX（Capecita... Observation	18 Years - 75 Years	Peking University Cancer Hospital & Institute
Efficacy of Postoperative Adjuvant Chemotherapy for Stage II Colon Cancer With High Risk Factors(EPAC1)	NCT03199989	Adjuvant Chemot...	CapeOX（Capecita... Observation	18 Years - 75 Years	Peking University Cancer Hospital & Institute

Spots Global Cancer Trial Database for capeox（capecitabine+oxaliplatin）