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

Peking University Cancer Hospital & Institute

Status and phase: Enrolling; Phase 3

Conditions: Adjuvant Chemotherapy

Treatments: Drug: CapeOX（Capecitabine+Oxaliplatin）; Other: Observation

Study type: Interventional

Funder types: Other

Identifiers

NCT03199989

PKUCH-C01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,254 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,254 participants in 2 patient groups

adjuvant chemotherapy group

Active Comparator group

Description:

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

Treatment:

Drug: CapeOX（Capecitabine+Oxaliplatin）

observation group

Experimental group

Description:

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

Treatment:

Other: Observation