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

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ClinicalTrials.gov Identifier: NCT03199989
Recruitment Status : Recruiting
First Posted : June 27, 2017
Last Update Posted : December 19, 2018
Sponsor:
Collaborators:
Peking Union Medical College Hospital
Peking University People's Hospital
Information provided by (Responsible Party):
Aiwen Wu, 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.

Condition or disease Intervention/treatment Phase
Adjuvant Chemotherapy Drug: CapeOX(Capecitabine+Oxaliplatin) Other: Observation Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1254 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: a prospertive randomized clinical trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Postoperative Adjuvant Chemotherapy for Stage II Colon Cancer With High Risk Factors(EPAC1)
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : July 31, 2024

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 3-year disease free survival [ Time Frame: At least 3 years after the last patient enrolled ]
    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 :
  1. 3-year overall survival [ Time Frame: At least 3 years after the last patient enrolled ]
    Overall survival was defined as the duration from randomization to death from any cause

  2. Rate of metastasis [ Time Frame: At least 3 years after the last patient enrolled ]
    Rate of metastasis in different groups

  3. Relationship between high risk factors and survival [ Time Frame: At least 3 years after the last patient enrolled ]
    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.

  4. Major adverse events [ Time Frame: At least 1 years after the last patient enrolled ]
    Toxic reaction in the chemotherapy group.Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03199989


Contacts
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Contact: Pengju Chen, M.D. +8613811403082 pengjuchen@163.com

Locations
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China
Beijing cancer hospital Recruiting
Beijing, China
Contact: Pengju Chen, M.D.         
Principal Investigator: Aiwen Wu, M.D.         
Sub-Investigator: Pengju Chen, M.D.         
Sponsors and Collaborators
Beijing Cancer Hospital
Peking Union Medical College Hospital
Peking University People's Hospital
Investigators
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Principal Investigator: Aiwen Wu, M.D. Beijing Cancer Hospital

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Responsible Party: Aiwen Wu, M.D. PH.D. Chief, Unit III & Ostomy Service, Gastrointestinal Cancer Center, Peking University Cancer Hospital & Institute, Beijing Cancer Hospital
ClinicalTrials.gov Identifier: NCT03199989     History of Changes
Other Study ID Numbers: PKUCH-C01
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: December 19, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Aiwen Wu, Beijing Cancer Hospital:
colon cancer
adjuvant chemotherapy
high risk

Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Capecitabine
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents