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

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

Sponsors

Lead sponsor: Beijing Cancer Hospital

Collaborator: Peking Union Medical College Hospital
Peking University People's Hospital

Source Beijing Cancer Hospital
Brief 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.

Overall Status Recruiting
Start Date June 1, 2017
Completion Date July 31, 2024
Primary Completion Date July 31, 2021
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
3-year disease free survival At least 3 years after the last patient enrolled
Secondary Outcome
Measure Time Frame
3-year overall survival At least 3 years after the last patient enrolled
Rate of metastasis At least 3 years after the last patient enrolled
Relationship between high risk factors and survival At least 3 years after the last patient enrolled
Major adverse events At least 1 years after the last patient enrolled
Enrollment 1254
Condition
Intervention

Intervention type: Drug

Intervention name: CapeOX(Capecitabine+Oxaliplatin)

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

Arm group label: adjuvant chemotherapy group

Intervention type: Other

Intervention name: Observation

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

Arm group label: observation group

Eligibility

Criteria:

Inclusion Criteria:

1. aged 18 to 75 years;

2. pathologically confirmed adenocarcinoma of the colon

3. after curative resection pathological stage was T3-4N0M0;

4. with at least one of the following factors:

1. T4 staging

2. lymph nodes number less than 12

3. poor differentiation (except MSI-H)

4. LVI or PNI

5. obstruction or perforation

6. Elevated preoperative serum CEA

5. ECOG Performance status 0-1

6. no evidence of distant metastases

7. no preoperative chemotherapy or chemoradiation therapy

8. ANC > 1.5 cells/mm3, HGB > 10.0 g/dL, PLT > 100,000/mm3, total bilirubin ≤ 1.5 xULN, AST≤ 3 x ULN, ALT ≤ 3 x ULN.

9. Patients must read, agree to, and sign a statement of Informed Consent prior to participation in this study.

Exclusion Criteria:

1. combined with other cancer

2. Creatinine level greater than 1.5 times the upper limit of normal.

3. Patients who have received preoperative chemotherapy or chemoradiotherapy.

4. Patients with a history of a prior malignancy within the past 5 years.

5. Women who are pregnant or breast-feeding.

6. patients may not complete the whole schedule of chemotherapy

7. Patients with any other concurrent medical or psychiatric condition or disease which would make them inappropriate candidates for entry into this study.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Aiwen Wu, M.D. Principal Investigator Beijing Cancer Hospital
Overall Contact

Last name: Pengju Chen, M.D.

Phone: +8613811403082

Email: [email protected]

Location
facility status contact investigator Beijing cancer hospital Pengju Chen, M.D. Aiwen Wu, M.D. Principal Investigator Pengju Chen, M.D. Sub-Investigator
Location Countries

China

Verification Date

March 2020

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Beijing Cancer Hospital

Investigator full name: Aiwen Wu

Investigator title: M.D. PH.D. Chief, Unit III & Ostomy Service, Gastrointestinal Cancer Center, Peking University Cancer Hospital & Institute

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: adjuvant chemotherapy group

Arm group type: Active Comparator

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

Arm group label: observation group

Arm group type: Experimental

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

Acronym EPAC1
Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: a prospertive randomized clinical trial

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov