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

Fudan University

Status and phase: Completed; Phase 4

Conditions: Colorectal Cancer

Treatments: Drug: 8 cycles of oxaliplatine based adjuvant chemotherapy; Drug: 12 cycles of oxaliplatine based adjuvant chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00868816

2009-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

1

Experimental group

Description:

12 cycles of oxaliplatine based adjuvant chemotherapy

Treatment:

Drug: 12 cycles of oxaliplatine based adjuvant chemotherapy

2

Active Comparator group

Description:

8 cycles of oxaliplatine based adjuvant chemotherapy

Treatment:

Drug: 8 cycles of oxaliplatine based adjuvant chemotherapy