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Trial record 10 of 300 for:    colon cancer AND Capecitabine AND chemotherapy

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

Tracking Information
First Submitted Date  ICMJE June 4, 2017
First Posted Date  ICMJE June 27, 2017
Last Update Posted Date December 19, 2018
Actual Study Start Date  ICMJE June 1, 2017
Estimated Primary Completion Date July 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03199989 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2017)
  • 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
  • Rate of metastasis [ Time Frame: At least 3 years after the last patient enrolled ]
    Rate of metastasis in different groups
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Postoperative Adjuvant Chemotherapy for Stage II Colon Cancer With High Risk Factors(EPAC1)
Official Title  ICMJE Efficacy of Postoperative Adjuvant Chemotherapy for Stage II Colon Cancer With High Risk Factors(EPAC1)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
a prospertive randomized clinical trial
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Adjuvant Chemotherapy
Intervention  ICMJE
  • Drug: CapeOX(Capecitabine+Oxaliplatin)
    Patients enrolled in the chemotherapy group would receive postoperative chemotherapy CapeOX(Capecitabine+Oxaliplatin)for 6 months
  • Other: Observation
    Patients enrolled in the observation group would not receive any chemotherapy drugs just for observation
Study Arms  ICMJE
  • Active Comparator: adjuvant chemotherapy group
    patients enrolled int the adjuvant chemotherapy group will receive adjuvant chemotherapy[CapeOX(Capecitabine+Oxaliplatin)] by the current guidelines
    Intervention: Drug: CapeOX(Capecitabine+Oxaliplatin)
  • Experimental: observation group
    patients enrolled int the adjuvant chemotherapy group will not receive adjuvant chemotherapy just for observation
    Intervention: Other: Observation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 25, 2017)
1254
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2024
Estimated Primary Completion Date July 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pengju Chen, M.D. +8613811403082 pengjuchen@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03199989
Other Study ID Numbers  ICMJE PKUCH-C01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Aiwen Wu, Beijing Cancer Hospital
Study Sponsor  ICMJE Beijing Cancer Hospital
Collaborators  ICMJE
  • Peking Union Medical College Hospital
  • Peking University People's Hospital
Investigators  ICMJE
Principal Investigator: Aiwen Wu, M.D. Beijing Cancer Hospital
PRS Account Beijing Cancer Hospital
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP