Back to resultsEfficacy of Postoperative Adjuvant Chemotherapy for Stage II Colon Cancer With High Risk Factors(EPAC1) (EPAC1)
Primary Purpose
Adjuvant Chemotherapy
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
CapeOX（Capecitabine+Oxaliplatin）
Observation
Sponsored by
About this trial
This is an interventional treatment trial for Adjuvant Chemotherapy focused on measuring colon cancer, adjuvant chemotherapy, high risk
Eligibility Criteria
Inclusion Criteria:
- aged 18 to 75 years;
- pathologically confirmed adenocarcinoma of the colon
- after curative resection pathological stage was T3-4N0M0;
with at least one of the following factors:
- T4 staging
- lymph nodes number less than 12
- poor differentiation (except MSI-H)
- LVI or PNI
- obstruction or perforation
- Elevated preoperative serum CEA
- ECOG Performance status 0-1
- no evidence of distant metastases
- no preoperative chemotherapy or chemoradiation therapy
- 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.
- Patients must read, agree to, and sign a statement of Informed Consent prior to participation in this study.
Exclusion Criteria:
- combined with other cancer
- Creatinine level greater than 1.5 times the upper limit of normal.
- Patients who have received preoperative chemotherapy or chemoradiotherapy.
- Patients with a history of a prior malignancy within the past 5 years.
- Women who are pregnant or breast-feeding.
- patients may not complete the whole schedule of chemotherapy
- Patients with any other concurrent medical or psychiatric condition or disease which would make them inappropriate candidates for entry into this study.
Sites / Locations
- Beijing cancer hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
adjuvant chemotherapy group
observation group
Arm Description
patients enrolled int the adjuvant chemotherapy group will receive adjuvant chemotherapy[CapeOX（Capecitabine+Oxaliplatin）] by the current guidelines
patients enrolled int the adjuvant chemotherapy group will not receive adjuvant chemotherapy just for observation
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
3-year overall survival
Overall survival was defined as the duration from randomization to death from any cause
Rate of metastasis
Rate of metastasis in different groups
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.
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
Full Information
NCT ID
NCT03199989
First Posted
June 4, 2017
Last Updated
March 5, 2020
Sponsor
Peking University Cancer Hospital & Institute
Collaborators
Peking Union Medical College Hospital, Peking University People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03199989
Brief Title
Efficacy of Postoperative Adjuvant Chemotherapy for Stage II Colon Cancer With High Risk Factors(EPAC1)
Acronym
EPAC1
Official Title
Efficacy of Postoperative Adjuvant Chemotherapy for Stage II Colon Cancer With High Risk Factors(EPAC1)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
July 31, 2021 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University Cancer Hospital & Institute
Collaborators
Peking Union Medical College Hospital, Peking University People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adjuvant Chemotherapy
Keywords
colon cancer, adjuvant chemotherapy, high risk
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
a prospertive randomized clinical trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1254 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
adjuvant chemotherapy group
Arm Type
Active Comparator
Arm Description
patients enrolled int the adjuvant chemotherapy group will receive adjuvant chemotherapy[CapeOX（Capecitabine+Oxaliplatin）] by the current guidelines
Arm Title
observation group
Arm Type
Experimental
Arm Description
patients enrolled int the adjuvant chemotherapy group will not receive adjuvant chemotherapy just for observation
Intervention Type
Drug
Intervention Name(s)
CapeOX（Capecitabine+Oxaliplatin）
Intervention Description
Patients enrolled in the chemotherapy group would receive postoperative chemotherapy CapeOX（Capecitabine+Oxaliplatin）for 6 months
Intervention Type
Other
Intervention Name(s)
Observation
Intervention Description
Patients enrolled in the observation group would not receive any chemotherapy drugs just for observation
Primary Outcome Measure Information:
Title
3-year disease free survival
Description
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.
Time Frame
At least 3 years after the last patient enrolled
Secondary Outcome Measure Information:
Title
3-year overall survival
Description
Overall survival was defined as the duration from randomization to death from any cause
Time Frame
At least 3 years after the last patient enrolled
Title
Rate of metastasis
Description
Rate of metastasis in different groups
Time Frame
At least 3 years after the last patient enrolled
Title
Relationship between high risk factors and survival
Description
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.
Time Frame
At least 3 years after the last patient enrolled
Title
Major adverse events
Description
Toxic reaction in the chemotherapy group.Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Time Frame
At least 1 years after the last patient enrolled
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
aged 18 to 75 years;
pathologically confirmed adenocarcinoma of the colon
after curative resection pathological stage was T3-4N0M0;
with at least one of the following factors:
T4 staging
lymph nodes number less than 12
poor differentiation (except MSI-H)
LVI or PNI
obstruction or perforation
Elevated preoperative serum CEA
ECOG Performance status 0-1
no evidence of distant metastases
no preoperative chemotherapy or chemoradiation therapy
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.
Patients must read, agree to, and sign a statement of Informed Consent prior to participation in this study.
Exclusion Criteria:
combined with other cancer
Creatinine level greater than 1.5 times the upper limit of normal.
Patients who have received preoperative chemotherapy or chemoradiotherapy.
Patients with a history of a prior malignancy within the past 5 years.
Women who are pregnant or breast-feeding.
patients may not complete the whole schedule of chemotherapy
Patients with any other concurrent medical or psychiatric condition or disease which would make them inappropriate candidates for entry into this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pengju Chen, M.D.
Phone
+8613811403082
Email
pengjuchen@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aiwen Wu, M.D.
Organizational Affiliation
Peking University Cancer Hospital & Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing cancer hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pengju Chen, M.D.
First Name & Middle Initial & Last Name & Degree
Aiwen Wu, M.D.
First Name & Middle Initial & Last Name & Degree
Pengju Chen, M.D.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of Postoperative Adjuvant Chemotherapy for Stage II Colon Cancer With High Risk Factors(EPAC1)
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