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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.
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
Age
18 - 70 years
Sex
ALL
Healthy Volunteers
No
Kyungpook National University Medical center
Daegu, South Korea
Jun Seok Park
Daegu, South Korea
Start Date
January 13, 2013
Primary Completion Date
June 19, 2024
Completion Date
December 28, 2026
Last Updated
February 12, 2026
303
ACTUAL participants
timing to initiate the adjuvant FOLFOX chemotherapy
DRUG
Lead Sponsor
Kyungpook National University Hospital
NCT04704661
NCT04674267
Data Source & Attribution
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