Multi-Centre Phase III Open Label Randomized Trial Comparing CPT-11 In Combination With A 5-FU/FA Infusional Regimen To The Same 5-FU/FA Infusional Regimen Alone, As Adjuvant Treatment After Resection Of Liver Metastases For Colorectal Cancer.
18 Years
75 Years
Both
Colorectal Neoplasms, Liver Neoplasms
Trial Information
Multi-Centre Phase III Open Label Randomized Trial Comparing CPT-11 In Combination With A 5-FU/FA Infusional Regimen To The Same 5-FU/FA Infusional Regimen Alone, As Adjuvant Treatment After Resection Of Liver Metastases For Colorectal Cancer.
Inclusion Criteria:
- Histologically proven adenocarcinoma of the colon or rectum with complete resection
of primary tumour.
- Complete surgical resection (R0) of the liver metastasis(es) within a minimum of 3
weeks, and a maximum of 8 weeks prior to the first study treatment infusion.
- Exclusively hepatic metastasis (es) : absence of bone, lung and brain metastases.
Exclusion Criteria:
- Prior hepatic radiation or resection.
- Prior radiofrequency ablation or cryoablation Incomplete surgical resection of liver
metastasis (es).
- Prior chemotherapy for metastatic disease.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Disease Free Survival (DFS)
Outcome Description:
time interval between the date of randomization and the earliest date of local, regional or distant relapse, or death due to cancer.
Outcome Time Frame:
last tumor assessment date or cut-off date, whichever is earlier.
Safety Issue:
No
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study ID:
CPT-GMA-301
NCT ID:
NCT00143403
Start Date:
December 2001
Completion Date:
September 2009
Related Keywords:
- Colorectal Neoplasms
- Liver Neoplasms
- Neoplasms
- Colorectal Neoplasms
- Liver Neoplasms
- Neoplasm Metastasis
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