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Early Commencement of Adjuvant Chemotherapy for Colon Cancer (ECTX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01460589
Recruitment Status : Active, not recruiting
First Posted : October 27, 2011
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
Gyu-Seog Choi, Kyungpook National University Hospital

Tracking Information
First Submitted Date  ICMJE October 25, 2011
First Posted Date  ICMJE October 27, 2011
Last Update Posted Date June 4, 2020
Study Start Date  ICMJE November 2011
Estimated Primary Completion Date October 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 5, 2011)
3-year disease free survival rate [ Time Frame: up to 3 years after operation ]
A survival analysis will be performed using the Kaplan-Meier method, for which a comparison of the survival curve will also made using a Log-rank test.
Original Primary Outcome Measures  ICMJE
 (submitted: October 26, 2011)
3-year survival rate [ Time Frame: up to 3 years after operation ]
A survival analysis will be performed using the Kaplan-Meier method, for which a comparison of the survival curve will also made using a Log-rank test.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 26, 2011)
  • short-term cumulative surgery-related complications during chemotherapy [ Time Frame: up to 26 weeks after operation ]
    A comparison of the postoperative recovery variables, the postoperative complications and mortality
  • side effects of chemotherapy [ Time Frame: during chemotherapy period ]
    check Anemia, Leukopenia, Neutropenia, Thrombocytopenia, Edema, Fever, Insomnia, Asthenia, Anorexia, Nausea, Vomiting, Constipation, Diarrhea, Hand foot syndrome, Dyspepsia, Creatinine, AST, ALT, Bilirubin, abdominal pain, GI bleeding, diarrhea
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 Early Commencement of Adjuvant Chemotherapy for Colon Cancer
Official Title  ICMJE Early Commencement of Adjuvant Chemotherapy for Stage III Colon Cancer: a Multicenter Randomized Trial
Brief Summary

This study sets up the final study end point and three detailed goals as the following.

The main objective of study: This trial is done to assess the safety and benefit of early adjuvant chemotherapy from 10 to 14 days after surgery compared with conventional commencement after 2weeks for treatment of patients with colon cancer.

Detailed goal of study:

The primary endpoint: This study is designed to assess whether early commencement of adjuvant chemotherapy improves the 3-year disease-free survival, overall survival and recurrence rate.

The secondary endpoint: This study aims to compare short-term cumulative complications between early and conventional commencement of adjuvant chemotherapy after laparoscopic resection of colon cancer. This study will also assess the quality of life and side effects of chemotherapy.

Detailed Description

Chemotherapy regimen: FOLFOX-6, every 2weeks, total 12 cycles treatment

  • day1: Oxaliplatin 85mg/m2
  • day1: Leucovorin 200mg/m2
  • day1: 5-FU 400mg/m2 IV bolus

    • 2,400mg/m2 over 46 hours
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colon Cancer
Intervention  ICMJE Procedure: timing to initiate the adjuvant chemotherapy
Chemotherapy regimen: FOLFOX-6, every 2weeks, total 12 cycles treatment day1: Oxaliplatin 85mg/m2 day1: Leucovorin 200mg/m2 day1: 5-FU 400mg/m2 IV bolus and 2,400mg/m2 over 46 hours
Other Name: early commencement of chemotherapy
Study Arms  ICMJE
  • Experimental: early commencement
    Individuals who initiate the adjuvant chemotherapy from 10 to 14 days after surgery
    Intervention: Procedure: timing to initiate the adjuvant chemotherapy
  • Active Comparator: conventional commencement
    Individuals who initiate the adjuvant chemotherapy after 14 days after surgery
    Intervention: Procedure: timing to initiate the adjuvant chemotherapy
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 Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: January 23, 2018)
440
Original Estimated Enrollment  ICMJE
 (submitted: October 26, 2011)
198
Estimated Study Completion Date  ICMJE December 2024
Estimated Primary Completion Date October 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Eligibility rule of enrollment
  • Rectal adenocarcinoma that were 15 cm or more from the anal verge
  • pathologically diagnosed stage II or III disease
  • patients who meet the discharge criteria within 10days after surgery
  • Patients with adequate hepatic, renal, and bone marrow function, and a left ventricular ejection fraction of 55% or higher measured by echocardiography

Exclusion Criteria:

  • An ineligibility to participate in the clinical study based on the judgment of investigators from a legal perspective
  • A past history of chemotherapy
  • tumor with obstruction or perforation
  • tumor with distant metastases
  • synchronous tumor
  • relative or absolute contraindications of chemotherapy
  • Recent MI, CVA, nitrate medication
  • Severe cardiovascular disease, psychiatric disease
  • Severe hepatic dysfunction (GOT, GPT ≥100IU/L)
  • Renal dysfunction (Cr ≥2mg/dl)
  • The concurrent presence of other severe medical diseases
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01460589
Other Study ID Numbers  ICMJE KNUHCRC004
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gyu-Seog Choi, Kyungpook National University Hospital
Study Sponsor  ICMJE Kyungpook National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Gyu seog Choi, M.D. Kyunpook National Univercity Medical Center
PRS Account Kyungpook National University Hospital
Verification Date June 2020

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