Oxaliplatine Based Adjuvant Chemotherapy for Stage II/III Colorectal Cancer: 8 Cycles Versus 12 Cycles

Phase 4

Completed

• Conditions: Colorectal Cancer
• Interventions: Drug: 12 cycles of oxaliplatine based adjuvant chemotherapy; Drug: 8 cycles of oxaliplatine based adjuvant chemotherapy

• Registration Number: NCT00868816
• Lead Sponsor: Fudan University

Brief Summary

The purpose of this study is to investigate which oxaliplatie based adjuvant method (8 cycles or 12 cycles) is better for patients receiving curative colorectal cancer resection.

Detailed Description

We administered 5-FU, lv and Oxaliplatin as adjuvant chemotherapy (3 weeks per cycle) to patients with Stage II or Stage III colorectal cancer. The study endpoints were disease-free survival, overall survival, and liver metastasis-free survival as evaluated by intent-to-treat analysis.

Study Timeline

• Study Start: 2005-01
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2009-03
• Study First Submitted: 2009-03-24
• Study First Submitted QC: 2009-03-24
• Last Update Submitted: 2009-03-24
• Study First Posted: 2009-03-25
• Last Update Posted: 2009-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• age < 75 years with histologically proven adenocarcinoma of the colon or rectum
• no severe major organ dysfunction
• WHO performance status of 0 or 1
• Stage II (T3-4, N0, M0) or Stage III (T0-4, N1-2, M0) disease (according to the 1997 revision of the International Union Against Cancer TNM staging system)

Exclusion Criteria

• age >= 75
• severe major organ dysfunction
• WHO performance status of >1
• Stage I or Stage IV

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	12 cycles of oxaliplatine based adjuvant chemotherapy	12 cycles of oxaliplatine based adjuvant chemotherapy
2	8 cycles of oxaliplatine based adjuvant chemotherapy	8 cycles of oxaliplatine based adjuvant chemotherapy

Primary Outcome Measures

Name	Time	Method
disease-free survival	5 years after operation

Secondary Outcome Measures

Name	Time	Method
overall survival liver metastasis-free survival	5 years after operation

Trial Locations

Locations (1)

Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China