Status:
UNKNOWN
Early Commencement of Adjuvant Chemotherapy for Colon Cancer
Lead Sponsor:
Kyungpook National University Hospital
Conditions:
Colon Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief 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...
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
440 Patients enrolled
Trial Details
Trial ID
NCT01460589
Start Date
November 1 2011
End Date
December 1 2024
Last Update
December 22 2022
Active Locations (2)
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1
Kyungpook National University Hospital
Daegu, South Korea, 700-721
2
Gyu seog Choi
Daegu, South Korea