Efficacy of Postoperative Adjuvant Chemotherapy for Stage II Colon Cancer With High Risk Factors(EPAC1)
NCT ID: NCT03199989
Last Updated: 2020-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
1254 participants
INTERVENTIONAL
2017-06-01
2024-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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adjuvant chemotherapy group
patients enrolled int the adjuvant chemotherapy group will receive adjuvant chemotherapy\[CapeOX（Capecitabine+Oxaliplatin）\] by the current guidelines
CapeOX（Capecitabine+Oxaliplatin）
Patients enrolled in the chemotherapy group would receive postoperative chemotherapy CapeOX（Capecitabine+Oxaliplatin）for 6 months
observation group
patients enrolled int the adjuvant chemotherapy group will not receive adjuvant chemotherapy just for observation
Observation
Patients enrolled in the observation group would not receive any chemotherapy drugs just for observation
Interventions
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CapeOX（Capecitabine+Oxaliplatin）
Patients enrolled in the chemotherapy group would receive postoperative chemotherapy CapeOX（Capecitabine+Oxaliplatin）for 6 months
Observation
Patients enrolled in the observation group would not receive any chemotherapy drugs just for observation
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Peking Union Medical College Hospital
OTHER
Peking University People's Hospital
OTHER
Peking University Cancer Hospital & Institute
OTHER
Responsible Party
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Aiwen Wu
M.D. PH.D. Chief, Unit III & Ostomy Service, Gastrointestinal Cancer Center, Peking University Cancer Hospital & Institute
Principal Investigators
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Aiwen Wu, M.D.
Role: PRINCIPAL_INVESTIGATOR
Peking University Cancer Hospital & Institute
Locations
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Beijing cancer hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Pengju Chen, M.D.
Role: primary
Other Identifiers
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PKUCH-C01
Identifier Type: -
Identifier Source: org_study_id
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