Status:
COMPLETED
Safety and Efficacy Study of XELOX vs. Oxaliplatin+5-FU CI as First Line Treatment in Metastatic Colorectal Cancer
Lead Sponsor:
Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine time to disease progression of combination therapy with capecitabine and oxaliplatin (XELOX) vs. oxaliplatin and 5-fluorouracil in continous infusion (5-FU CI...
Detailed Description
The purpose of this study is to determine time to disease progression of combination therapy with capecitabine and oxaliplatin (XELOX) vs. oxaliplatin and 5-fluorouracil in continous infusion (5-FU CI...
Eligibility Criteria
Inclusion
- Written informed consent. Men and women \> or = 18 years Karnofsky functional status \>or=70% at the time of enrollment in study Histologically confirmed diagnosis of CRC Patients must not have received chemotherapy (exception: adjuvant treatment \> 12 months following conclusion of treatment) Presence of at least one lesion detectable by two-dimensional measurement.. Life expectancy greater than 3 months.
Exclusion
- Pregnant or nursing woman Prior administration of systemic immunotherapy, chemotherapy (exception: 5-FU as adjuvant treatment \> 12 months following conclusion of treatment) Evidence of allergic reaction to any of the treatment components Clinically relevant myocardial disease or history of myocardial infarction in the past 12 months Documented or suspected cerebral and/or leptomeningeal metastases. Prior malignant tumour in past 5 years, except history of basal cell skin carcinoma or pre-invasive cervical carcinoma.
- Neutrophil count \< 1.5 x 109/l , platelets \< 100 X 109/l serum creatinine \> 1.5 x ULN. Total bilirubin count \> 2 x ULN Alkaline Phosphatase \> \> 2.5 x ULN (\> 5 x ULN if there are hepatic metastases) Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) \> 2.5 x ULN (\> 5 x ULN if there are hepatic metastases, \> 10 x ULN if there are bone metastases) Creatinine clearance \< 30 ml/min Surgery within 4 weeks prior to enrollment in the study. Any investigational drug during the 4 weeks prior to enrolment. Uncontrolled active infection Any medical or psychological disorder which, in the opinion of the investigator, does not allow the patient to conclude the study or sign the informed consent
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Key Trial Info
Start Date :
April 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2005
Estimated Enrollment :
348 Patients enrolled
Trial Details
Trial ID
NCT00202774
Start Date
April 1 2002
End Date
December 1 2005
Last Update
April 12 2023
Active Locations (1)
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1
Spanish Cooperative Group for Gastrointestinal Tumour Therapy (TTD)
Madrid, Spain, 28046