Colorectal Cancer
Conditions
Keywords
oxaliplatine, colorectal cancer, chemotherapy
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.
Interventions
DRUG12 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
DRUG8 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
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| disease-free survival | 5 years after operation |
Secondary
| Measure | Time frame |
|---|---|
| overall survival liver metastasis-free survival | 5 years after operation |
Countries
China
Outcome results
None listed