Efficacy of Postoperative Adjuvant Chemotherapy for Stage II Colon Cancer With High Risk Factors(EPAC1) (EPAC1)
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|ClinicalTrials.gov Identifier: NCT03199989|
Recruitment Status : Recruiting
First Posted : June 27, 2017
Last Update Posted : December 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Adjuvant Chemotherapy||Drug: CapeOX（Capecitabine+Oxaliplatin） Other: Observation||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1254 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||a prospertive randomized clinical trial|
|Masking:||None (Open Label)|
|Official Title:||Efficacy of Postoperative Adjuvant Chemotherapy for Stage II Colon Cancer With High Risk Factors(EPAC1)|
|Actual Study Start Date :||June 1, 2017|
|Estimated Primary Completion Date :||July 31, 2021|
|Estimated Study Completion Date :||July 31, 2024|
Active Comparator: adjuvant chemotherapy group
patients enrolled int the adjuvant chemotherapy group will receive adjuvant chemotherapy[CapeOX（Capecitabine+Oxaliplatin）] by the current guidelines
Patients enrolled in the chemotherapy group would receive postoperative chemotherapy CapeOX（Capecitabine+Oxaliplatin）for 6 months
Experimental: observation group
patients enrolled int the adjuvant chemotherapy group will not receive adjuvant chemotherapy just for observation
Patients enrolled in the observation group would not receive any chemotherapy drugs just for observation
- 3-year disease free survival [ Time Frame: At least 3 years after the last patient enrolled ]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.
- 3-year overall survival [ Time Frame: At least 3 years after the last patient enrolled ]Overall survival was defined as the duration from randomization to death from any cause
- Rate of metastasis [ Time Frame: At least 3 years after the last patient enrolled ]Rate of metastasis in different groups
- Relationship between high risk factors and survival [ Time Frame: At least 3 years after the last patient enrolled ]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.
- Major adverse events [ Time Frame: At least 1 years after the last patient enrolled ]Toxic reaction in the chemotherapy group.Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03199989
|Contact: Pengju Chen, M.D.||+email@example.com|
|Beijing cancer hospital||Recruiting|
|Contact: Pengju Chen, M.D.|
|Principal Investigator: Aiwen Wu, M.D.|
|Sub-Investigator: Pengju Chen, M.D.|
|Principal Investigator:||Aiwen Wu, M.D.||Beijing Cancer Hospital|