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ACTIVE NOT RECRUITING
NCT01460589
PHASE3

Early Commencement of Adjuvant Chemotherapy for Colon Cancer

Sponsor: Kyungpook National University Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

303

Start Date

2013-01-13

Completion Date

2026-12-28

Last Updated

2026-02-12

Healthy Volunteers

No

Conditions

Interventions

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

Locations (2)

Kyungpook National University Medical center

Daegu, South Korea

Jun Seok Park

Daegu, South Korea