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

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.

Study Overview

• Status: Recruiting
• Conditions: Adjuvant Chemotherapy
• Intervention / Treatment: Drug: CapeOX（Capecitabine+Oxaliplatin）; Other: Observation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 1254
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Pengju Chen, M.D.; Phone Number: +8613811403082; Email: pengjuchen@163.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Beijing Cancer Hospital
    • Contact: Pengju Chen, M.D.
    • Sub-Investigator: Pengju Chen, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: adjuvant chemotherapy group; patients enrolled int the adjuvant chemotherapy group will receive adjuvant chemotherapy[CapeOX（Capecitabine+Oxaliplatin）] by the current guidelines	Drug: CapeOX（Capecitabine+Oxaliplatin）; 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	Other: Observation; Patients enrolled in the observation group would not receive any chemotherapy drugs just for observation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3-year disease free survival	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.	At least 3 years after the last patient enrolled

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3-year overall survival	Overall survival was defined as the duration from randomization to death from any cause	At least 3 years after the last patient enrolled
Rate of metastasis	Rate of metastasis in different groups	At least 3 years after the last patient enrolled
Relationship between high risk factors and survival	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.	At least 3 years after the last patient enrolled
Major adverse events	Toxic reaction in the chemotherapy group.Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0	At least 1 years after the last patient enrolled

Collaborators and Investigators

• Sponsor: Peking University Cancer Hospital & Institute
• Collaborators: Peking University People's Hospital; Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Anticipated): July 31, 2021
• Study Completion (Anticipated): July 31, 2024

Study Registration Dates

• First Submitted: June 4, 2017
• First Submitted That Met QC Criteria: June 25, 2017
• First Posted (Actual): June 27, 2017

Study Record Updates

• Last Update Posted (Actual): March 6, 2020
• Last Update Submitted That Met QC Criteria: March 5, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: colon cancer; adjuvant chemotherapy; high risk
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Capecitabine; Oxaliplatin
• Other Study ID Numbers: PKUCH-C01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No