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Sponsored by: |
Spanish Cooperative Group for Gastrointestinal Tumour Therapy |
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Information provided by: | Spanish Cooperative Group for Gastrointestinal Tumour Therapy |
ClinicalTrials.gov Identifier: | NCT00202774 |
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
Condition | Intervention | Phase |
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Colorectal Cancer |
Drug: (capecitabine, oxaliplatin, 5-fluorouracil) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 348 |
Study Start Date: | April 2002 |
Estimated Study Completion Date: | December 2005 |
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
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
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Spain | |
Spanish Cooperative Group for Gastrointestinal Tumour Therapy (TTD) | |
Madrid, Spain, 28046 |
Study Chair: | Enrique Aranda | Spanish Cooperative Group for Gastrointestinal Tumour Therapy (TTD) |
Study Chair: | Eduardo Díaz-Rubio | Spanish Cooperative Group for Gastrointestinal Tumour Therapy (TTD) |
Study ID Numbers: | 03-TTD-01 |
Study First Received: | September 12, 2005 |
Last Updated: | September 12, 2005 |
ClinicalTrials.gov Identifier: | NCT00202774 History of Changes |
Health Authority: | Spain: Spanish Agency of Medicines |
colorectal cancer, capecitabine, oxaliplatin, 5-fluorouracil |
Antimetabolites Capecitabine Digestive System Neoplasms Immunologic Factors Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Immunosuppressive Agents |
Rectal Diseases Intestinal Neoplasms Oxaliplatin Digestive System Diseases Fluorouracil Gastrointestinal Neoplasms Colorectal Neoplasms |
Antimetabolites Capecitabine Antimetabolites, Antineoplastic Digestive System Neoplasms Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gastrointestinal Diseases Physiological Effects of Drugs Colonic Diseases Intestinal Diseases Immunosuppressive Agents |
Rectal Diseases Pharmacologic Actions Intestinal Neoplasms Oxaliplatin Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Fluorouracil Gastrointestinal Neoplasms Colorectal Neoplasms |