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Clinical Trials in South Korea / NCT01460589
Active, not recruiting Phase 3

Early Commencement of Adjuvant Chemotherapy for Colon Cancer

NCT01460589 · tracked via the Priya Life Science South Korea tracker
Sponsor
Kyungpook National University Hospital
Phase
Phase 3
Started
2013-01-13
Last updated
2026-02-12

Condition(s) studied

Colon Cancer

Investigational drug(s) / intervention(s)

timing to initiate the adjuvant FOLFOX chemotherapy

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • 3-year disease free survival rate — up to 3 years after operation
    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.

Trial sites (2)

FacilityCityRegionStatus
Kyungpook National University Medical center Daegu South Korea
Jun Seok Park Daegu South Korea

More Kyungpook National University Hospital trials in South Korea

The Treatment Effect for Asymptomatic Common Bile Duct Stone Recruiting
Neoadjuvant FOLFOX Chemotherapy for Patients With Locally Advanced Colon Cancer Active, not recruiting
Analysis of Biomarkers From Patients With Chorioretinal Diseases Recruiting
Preoperative Sequential Short-course Radiation Therapy and FOLFOX for Locally Advanced Rectal Cancer Active, not recruiting
Inflammatory Bowel Disease Registry in Daegu-Gyeongbuk Recruiting

Other trials for the same condition

A Study of Selpercatinib (LOXO-292) in Participants With Advanced Solid Tumors, RET Fusion-Positive Solid Tumors, and Medullary Thyroid Cancer (LIBRETTO-001) Active, not recruiting
A Study of PHN-012 in Patients With Advanced Solid Tumors Recruiting
Neoadjuvant FOLFOX Chemotherapy for Patients With Locally Advanced Colon Cancer Active, not recruiting
Platform Study of Circulating Tumor DNA Directed Adjuvant Chemotherapy in Colon Cancer (KCSG CO22-12) Recruiting
A Study to Investigate the Safety, Pharmacokinetics, and Preliminary Effectiveness of GSK4418959 Alone or in Combination With Other Anti-cancer Agents in Participants With Solid Tumors Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT01460589 on ClinicalTrials.gov ↗ ← All trials in South Korea