Safety and Efficacy Study of XELOX vs. Oxaliplatin+5-FU CI as First Line Treatment in Metastatic Colorectal Cancer

Study Overview
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Brief Summary
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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) as first line treatment in advanced or metastatic colorectal cancer

Detailed Description
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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) as first line treatment in advanced or metastatic colorectal cancer

Official Title
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Phase III, Multicenter, Ramdomised, Open-label, Study to Evaluate the Safety and Efficacy of Combination Therapy With XELOX vs. Oxaliplatin and 5-FU CI as First Line Treatment in Advanced or Metastatic Colorectal Cancer

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: (capecitabine, oxaliplatin, 5-fluorouracil)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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 -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: (capecitabine, oxaliplatin, 5-fluorouracil)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine time to disease progression |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine safety of combination, objetive response rate, time to onset of response , duration of response, time to treatment failure, one year survival time, overall survival time |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colorectal cancer, capecitabine, oxaliplatin, 5-fluorouracil