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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: December 5, 2011
Last verified: November 2011
History of Changes

October 25, 2011
December 5, 2011
November 2011
October 2012   (final data collection date for primary outcome measure)
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.
3-year 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.
Complete list of historical versions of study NCT01460589 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Early Commencement of Adjuvant Chemotherapy for Colon Cancer
Not Provided

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.

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
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Colon Cancer
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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
198
October 2015
October 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01460589
KNUHCRC004
Yes
Gyu-Seog Choi, Kyungpook National University
Kyungpook National University
Not Provided
Study Chair: Gyu seog Choi, M.D. Kyunpook National Univercity Medical Center
Kyungpook National University
November 2011

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