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Sponsors and Collaborators: |
Dutch Colorectal Cancer Group Koningin Wilhelmina Fonds (Dutch Cancer Fund) Sanofi-Aventis Hoffmann-La Roche |
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Information provided by: | Dutch Colorectal Cancer Group |
ClinicalTrials.gov Identifier: | NCT00312000 |
Primary objective:To assess the efficacy, defined as overall survival, of sequential versus combination chemotherapy for advanced colorectal cancer (CRC). Methodology Open, randomised multicenter phase III study. Randomisation by centre will be centralized. 820 patiënts with histologically proven advanced CRC; not amenable to curative surgery. Measurable or evaluable disease. Age 18 years and above. WHO performance status 0-2.
Test products:
Arm A: First line: capecitabine capecitabine 1250 mg/m2 orally b.i.d. on day 1-14 (q3),until progression or unacceptable toxicity. Second line: irinotecan 350 mg/m2 IV infusion on day 1 (q3),until progression or unacceptable toxicity. Third line: oxaliplatin 130 mg/m2 IV infusion on day 1 and capecitabine 1000 mg/m2 orally b.i.d. on day 1-14 (q3). Arm B: First line: irinotecan 250 mg/m2 IV infusion in 30 minutes on day 1 and capecitabine 1000 mg/m2 orally b.i.d. on day 1-14 (q3), until progression or unacceptable toxicity. Second line: oxaliplatin 130 mg/m2 IV on day 1 and capecitabine 1000 mg/m2 orally b.i.d. on day 1-14 (q3), until progression or unacceptable toxicity. Patients will be followed by CT-scan every 9 weeks for response while on treatment, or at any other moment when progression is suspected. After cessation of chemotherapy, patients will be followed every 3 months until death.
Clinical and laboratory toxicity/symptomatology will be graded according to NCI common criteria.
Condition | Intervention | Phase |
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Advanced Colorectal Cancer |
Drug: capecitabine-irinotecan Drug: capecitabine+irinotecan (1st line) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomised Study of Sequential Versus Combination Chemotherapy in Patients With Previously Untreated Advanced Colorectal Carcinoma |
Enrollment: | 820 |
Study Start Date: | January 2003 |
Study Completion Date: | December 2006 |
Primary Completion Date: | February 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1Capecitabine-irinotecan: Active Comparator
1st line- 2nd line (3rd line oxaliplatin plus capecitabine)
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Drug: capecitabine-irinotecan
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2capecitabine plus irinotecan: Experimental
1st line (2nd line oxaliplatin plus capecitabine)
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Drug: capecitabine+irinotecan (1st line)
q 3 w irinotecan 250 mg/m2 IV infusion in 30 minutes on day 1 2 hours after discontinuation of the infusion followed by capecitabine 1000 mg/m2 orally b.i.d. on day 1-14
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Histology and staging disease
General conditions
Other
Exclusion Criteria:
General conditions
Prior or current history
Concomitant treatments
Principal Investigator: | C. J. A. Punt, Prof.Dr. | University Medical Center St. Radboud, Nijmegen, The Netherlands |
Responsible Party: | DCCG ( C.J.A. Punt, MD PhD ) |
Study ID Numbers: | CAIRO1 |
Study First Received: | April 5, 2006 |
Last Updated: | September 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00312000 History of Changes |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
colorectal cancer capecitabine irinotecan oxaliplatin |
Antimetabolites Capecitabine Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Irinotecan Intestinal Diseases Rectal Diseases |
Intestinal Neoplasms Carcinoma Oxaliplatin Digestive System Diseases Gastrointestinal Neoplasms Antineoplastic Agents, Phytogenic Colorectal Neoplasms |
Antimetabolites Capecitabine Antimetabolites, Antineoplastic Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gastrointestinal Diseases Colonic Diseases Irinotecan Enzyme Inhibitors Intestinal Diseases |
Rectal Diseases Pharmacologic Actions Intestinal Neoplasms Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Gastrointestinal Neoplasms Antineoplastic Agents, Phytogenic Colorectal Neoplasms |