Sequential Versus Combination Chemotherapy in Advanced Colorectal Carcinoma
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|ClinicalTrials.gov Identifier: NCT00312000|
Recruitment Status : Completed
First Posted : April 7, 2006
Last Update Posted : September 8, 2008
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.
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 or disease||Intervention/treatment||Phase|
|Advanced Colorectal Cancer||Drug: capecitabine-irinotecan Drug: capecitabine+irinotecan (1st line)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||820 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomised Study of Sequential Versus Combination Chemotherapy in Patients With Previously Untreated Advanced Colorectal Carcinoma|
|Study Start Date :||January 2003|
|Actual Primary Completion Date :||February 2006|
|Actual Study Completion Date :||December 2006|
Active Comparator: 1Capecitabine-irinotecan
1st line- 2nd line (3rd line oxaliplatin plus capecitabine)
Experimental: 2capecitabine plus irinotecan
1st line (2nd line oxaliplatin plus capecitabine)
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
- Overall survival [ Time Frame: study duration ]
- Tumour response [ Time Frame: study duration ]
- Progression free survival [ Time Frame: study duration ]
- Quality of life [ Time Frame: study duration ]
- Toxicity profile [ Time Frame: study duration ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00312000
|Principal Investigator:||C. J. A. Punt, Prof.Dr.||University Medical Center St. Radboud, Nijmegen, The Netherlands|