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

NCT ID: NCT00868816

Last Updated: 2009-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2007-12-31

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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

12 cycles of oxaliplatine based adjuvant chemotherapy

Group Type: EXPERIMENTAL

12 cycles of oxaliplatine based adjuvant chemotherapy

Intervention Type: DRUG

oxaliplatine 85 mg/㎡ d1, lv 200 mg/㎡ d1, 5-fu 1300 mg/㎡ ivgtt maintain for 48hr, every 3 weeks/cycle, 12 cycles

2

8 cycles of oxaliplatine based adjuvant chemotherapy

Group Type: ACTIVE_COMPARATOR

8 cycles of oxaliplatine based adjuvant chemotherapy

Intervention Type: DRUG

oxaliplatine 85 mg/㎡ d1, lv 200mg/㎡ d1, 5-fu 1300 mg/㎡ ivgtt maintain for 48hr, every 3 weeks/cycle, 8 cycles

Interventions

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

Intervention Type: DRUG

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

zhongshan hospital, fudan university

Principal Investigators

jianmin xu, MD, PHD

Role: STUDY_DIRECTOR

department of general surgery, zhongshan hospital, fudan university

Locations

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

2009-02

Identifier Type: -

Identifier Source: org_study_id