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Early Commencement of Adjuvant Chemotherapy for Colon Cancer (ECTX)

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ClinicalTrials.gov Identifier: NCT01460589
Recruitment Status : Recruiting
First Posted : October 27, 2011
Last Update Posted : January 25, 2018
Sponsor:
Information provided by (Responsible Party):
Gyu-Seog Choi, Kyungpook National University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Colon Cancer Procedure: timing to initiate the adjuvant chemotherapy Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Commencement of Adjuvant Chemotherapy for Stage III Colon Cancer: a Multicenter Randomized Trial
Study Start Date : November 2011
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : December 2018
Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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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): NCT01460589


Contacts
Contact: Gyu-Seog Choi, M.D. +82-53-200-2166 kyuschoi@mail.knu.ac.kr
Contact: Jun seok Park, M.D. +82-53-200-2166 caumed5@naver.com

Locations
Korea, Republic of
Kyungpook National University Hospital Recruiting
Daegu, Korea, Republic of, 700-721
Contact: Jun seok Park, M.D.    +82-53-420-6555    caumed5@naver.com   
Gyu seog Choi Recruiting
Daegu, Korea, Republic of
Contact: Jun seok Park, M.D.    +82-53-200-2166    caumed5@naver.com   
Sponsors and Collaborators
Kyungpook National University
Investigators
Study Chair: Gyu seog Choi, M.D. Kyunpook National Univercity Medical Center
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
First Posted: October 27, 2011    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018

Keywords provided by Gyu-Seog Choi, Kyungpook National University:
colon cancer
Chemotherapy
adjuvant

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases