A Prospective, Randomized, Control Trial of Oxaliplatine Based Adjuvant Chemotherapy for Stage II/III Colorectal Cancer: 8 Cycles vs 12 Cycles
18 Years
75 Years
Both
Colorectal Cancer
Trial Information
A Prospective, Randomized, Control Trial of Oxaliplatine Based Adjuvant Chemotherapy for Stage II/III Colorectal Cancer: 8 Cycles vs 12 Cycles
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
disease-free survival
Outcome Time Frame:
5 years after operation
Safety Issue:
No
Principal Investigator
jianmin xu, MD, PHD
Investigator Role:
Study Director
Investigator Affiliation:
department of general surgery, zhongshan hospital, fudan university
Authority:
China: Ministry of Health
Study ID:
2009-02
NCT ID:
NCT00868816
Start Date:
January 2005
Completion Date:
December 2007
Related Keywords:
- Colorectal Cancer
- oxaliplatine
- colorectal cancer
- chemotherapy
- Colorectal Neoplasms
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