Early Commencement of Adjuvant Chemotherapy for Colon Cancer (ECTX)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Gyu-Seog Choi, Kyungpook National University
ClinicalTrials.gov Identifier:
NCT01460589
First received: October 25, 2011
Last updated: July 11, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Colon Cancer
Procedure: timing to initiate the adjuvant chemotherapy
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Kyungpook National University:

Primary Outcome Measures:
  • 3-year disease free survival rate [ Time Frame: up to 3 years after operation ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • short-term cumulative surgery-related complications during chemotherapy [ Time Frame: up to 26 weeks after operation ] [ Designated as safety issue: Yes ]
    A comparison of the postoperative recovery variables, the postoperative complications and mortality

  • side effects of chemotherapy [ Time Frame: during chemotherapy period ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 198
Study Start Date: November 2011
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: early commencement
Individuals who initiate the adjuvant chemotherapy from 10 to 14 days after surgery
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
Active Comparator: conventional commencement
Individuals who initiate the adjuvant chemotherapy after 14 days after surgery
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

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
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01460589

Locations
Korea, Republic of
Gyu seog Choi
Daegu, Korea, Republic of
Kyungpook National University Hospital
Daegu, Korea, Republic of, 700-721
Sponsors and Collaborators
Kyungpook National University
Investigators
Study Chair: Gyu seog Choi, M.D. Kyunpook National Univercity Medical Center
  More Information

No publications provided

Responsible Party: Gyu-Seog Choi, Director, Head of colorectal cancer center, Principal Investigator, Professor, Kyungpook National University
ClinicalTrials.gov Identifier: NCT01460589     History of Changes
Other Study ID Numbers: KNUHCRC004
Study First Received: October 25, 2011
Last Updated: July 11, 2013
Health Authority: South Korea: Institutional Review Board

Keywords provided by Kyungpook National University:
colon cancer
Chemotherapy
adjuvant

ClinicalTrials.gov processed this record on October 16, 2014