Early Commencement of Adjuvant Chemotherapy for Colon Cancer (ECTX)

Early Commencement of Adjuvant Chemotherapy for Stage III Colon Cancer: a Multicenter Randomized Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Colon Cancer
• Intervention / Treatment: Procedure: timing to initiate the adjuvant 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: Interventional
• Enrollment (Anticipated): 440
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daegu, Korea, Republic of, 700-721
    • Kyungpook National University Hospital
  • Daegu, Korea, Republic of
    • Gyu seog Choi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: early commencement of chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 3 years after operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
short-term cumulative surgery-related complications during chemotherapy	A comparison of the postoperative recovery variables, the postoperative complications and mortality	up to 26 weeks after operation
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	during chemotherapy period

Collaborators and Investigators

• Sponsor: Kyungpook National University Hospital
• Investigators: Study Chair: Gyu seog Choi, M.D., Kyunpook National Univercity Medical Center

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Anticipated): October 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: October 25, 2011
• First Submitted That Met QC Criteria: October 26, 2011
• First Posted (Estimate): October 27, 2011

Study Record Updates

• Last Update Posted (Estimate): December 22, 2022
• Last Update Submitted That Met QC Criteria: December 21, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: adjuvant; colon cancer; Chemotherapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: KNUHCRC004