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

Colorectal Cancer Clinical Trial

Official title:

A Prospective, Randomized, Control Trial of Oxaliplatine Based Adjuvant Chemotherapy for Stage II/III Colorectal Cancer: 8 Cycles vs 12 Cycles

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00868816
• Other study ID #: 2009-02
• Status: Completed
• Phase: Phase 4
• First received: March 24, 2009
• Last updated: March 24, 2009
• Start date: January 2005
• Est. completion date: December 2007

Study information

• Verified date: March 2009
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• 12 cycles of oxaliplatine based adjuvant chemotherapy
oxaliplatine 85 mg/? d1, lv 200 mg/? d1, 5-fu 1300 mg/? ivgtt maintain for 48hr, every 3 weeks/cycle, 12 cycles
• 8 cycles of oxaliplatine based adjuvant chemotherapy
oxaliplatine 85 mg/? d1, lv 200mg/? d1, 5-fu 1300 mg/? ivgtt maintain for 48hr, every 3 weeks/cycle, 8 cycles

Locations

Country	Name	City	State
China	Zhongshan Hospital, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease-free survival		5 years after operation	No
Secondary	overall survival liver metastasis-free survival		5 years after operation	No