NCT03199989

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,254 (estimated)
• Sponsor: Peking University Cancer Hospital & Institute · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Adjuvant Chemotherapy

Interventions

Type	Name	Description
DRUG	CapeOX（Capecitabine+Oxaliplatin）	Patients enrolled in the chemotherapy group would receive postoperative chemotherapy CapeOX（Capecitabine+Oxaliplatin）for 6 months
OTHER	Observation	Patients enrolled in the observation group would not receive any chemotherapy drugs just for observation

Timeline

• Start date: 2017-06-01
• Primary completion: 2021-07-31
• Completion: 2024-07-31
• First posted: 2017-06-27
• Last updated: 2020-03-06

Locations

1 site across 1 country: China