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Early Commencement of Adjuvant Chemotherapy for Colon Cancer (ECTX)

Primary Purpose

Colon Cancer

Status
Active
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
timing to initiate the adjuvant chemotherapy
Sponsored by
Kyungpook National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colon Cancer focused on measuring colon cancer, Chemotherapy, adjuvant

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kyungpook National University Hospital
  • Gyu seog Choi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

early commencement

conventional commencement

Arm Description

Individuals who initiate the adjuvant chemotherapy from 10 to 14 days after surgery

Individuals who initiate the adjuvant chemotherapy after 14 days after surgery

Outcomes

Primary Outcome Measures

3-year disease free survival rate
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
A comparison of the postoperative recovery variables, the postoperative complications and mortality
side effects of chemotherapy
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

Full Information

First Posted
October 25, 2011
Last Updated
December 21, 2022
Sponsor
Kyungpook National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01460589
Brief Title
Early Commencement of Adjuvant Chemotherapy for Colon Cancer
Acronym
ECTX
Official Title
Early Commencement of Adjuvant Chemotherapy for Stage III Colon Cancer: a Multicenter Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 2011 (undefined)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyungpook National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer
Keywords
colon cancer, Chemotherapy, adjuvant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
440 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
early commencement
Arm Type
Experimental
Arm Description
Individuals who initiate the adjuvant chemotherapy from 10 to 14 days after surgery
Arm Title
conventional commencement
Arm Type
Active Comparator
Arm Description
Individuals who initiate the adjuvant chemotherapy after 14 days after surgery
Intervention Type
Procedure
Intervention Name(s)
timing to initiate the adjuvant chemotherapy
Other Intervention Name(s)
early commencement of chemotherapy
Intervention 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 and 2,400mg/m2 over 46 hours
Primary Outcome Measure Information:
Title
3-year disease free survival rate
Description
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.
Time Frame
up to 3 years after operation
Secondary Outcome Measure Information:
Title
short-term cumulative surgery-related complications during chemotherapy
Description
A comparison of the postoperative recovery variables, the postoperative complications and mortality
Time Frame
up to 26 weeks after operation
Title
side effects of chemotherapy
Description
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
Time Frame
during chemotherapy period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gyu seog Choi, M.D.
Organizational Affiliation
Kyunpook National Univercity Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Kyungpook National University Hospital
City
Daegu
ZIP/Postal Code
700-721
Country
Korea, Republic of
Facility Name
Gyu seog Choi
City
Daegu
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Early Commencement of Adjuvant Chemotherapy for Colon Cancer

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