NCT01460589

Early Commencement of Adjuvant Chemotherapy for Colon Cancer

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 303 (actual)
• Sponsor: Kyungpook National University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Conditions

• Colon Cancer

Interventions

Type	Name	Description
DRUG	timing to initiate the adjuvant FOLFOX 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

Timeline

• Start date: 2013-01-13
• Primary completion: 2024-06-19
• Completion: 2026-12-28
• First posted: 2011-10-27
• Last updated: 2026-02-12

Locations

2 sites across 1 country: South Korea