drugset / Trial / NCT01460589

Early Commencement of Adjuvant Chemotherapy for Colon Cancer

NCT01460589 ↗

Phase 3 Active not recruiting 303 enrolled Kyungpook National University Hospital
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2013-01-13
Primary completion
2024-06-19
Completion
2026-12-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Leucovorin Small molecule 200 mg/m2 —
Subject Oxaliplatin Small molecule 85 mg/m2 —
Subject fluorouracil Small molecule 2400 mg/m2 Intravenous

Indications