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
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Tracking Information | ||||
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First Submitted Date ICMJE | April 5, 2006 | |||
First Posted Date ICMJE | April 7, 2006 | |||
Last Update Posted Date | September 8, 2008 | |||
Study Start Date ICMJE | January 2003 | |||
Actual Primary Completion Date | February 2006 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Overall survival [ Time Frame: study duration ] | |||
Original Primary Outcome Measures ICMJE |
Overall survival | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Sequential Versus Combination Chemotherapy in Advanced Colorectal Carcinoma | |||
Official Title ICMJE | A Randomised Study of Sequential Versus Combination Chemotherapy in Patients With Previously Untreated Advanced Colorectal Carcinoma | |||
Brief Summary | 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. |
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Detailed Description | Objectives: Primary objective: To assess the efficacy, defined as overall survival, of sequential versus combination chemotherapy for advanced CRC. Secondary objectives are to assess: To assess Tumour response (CR, PR or SD) Progression free survival Quality of life Toxicity profile Methodology Open, randomised multicenter phase III study. Randomisation by centre will be centralized by IKC. Number of patients 820 Main criteria for inclusion Histology and staging disease
General conditions
Main criteria for exclusion General conditions
Prior or current history
Concomitant treatments
Every 3 weeks (q 3): capecitabine 1250 mg/m2 orally b.i.d. on day 1-14. This schedule will be continued until progression or unacceptable toxicity. Continuation after 6 months without disease progression and/or severe toxicity at the investigator's discretion. Second line: irinotecan Every 3 weeks (q 3): irinotecan 350 mg/m2 IV infusion on day 1. This schedule will be continued until progression or unacceptable toxicity. Continuation after 6 months without disease progression and/or severe toxicity at the investigator's discretion. Third line: oxaliplatin plus capecitabine oxaliplatin 130 mg/m2 IV infusion on day 1 and capecitabine 1000 mg/m2 orally b.i.d. on day 1-14. This schedule will be continued until progression or unacceptable toxicity. Continuation after 6 months without disease progression and/or severe toxicity at the investigator's discretion. Arm B First line: irinotecan plus capecitabine Every 3 weeks (q 3): 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. This schedule will be continued until progression or unacceptable toxicity. Continuation after 6 months without disease progression and/or severe toxicity at the investigator's discretion. Second line: oxaliplatin plus capecitabine Every 3 weeks (q 3): oxaliplatin 130 mg/m2 IV infusion in 2 hours on day 1 and capecitabine 1000 mg/m2 orally b.i.d. on day 1-14. This schedule will be continued until progression or unacceptable toxicity. Continuation after 6 months without disease progression and/or severe toxicity at the investigator's discretion. Duration of treatment and follow-up Treatment is continued until disease 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. Death or progression should be reported whenever it occurs. Criteria for evaluation Efficacy All patients will be included in the survival analysis (intent-to-treat). All patients receiving > 9 weeks of treatment (i.e. 3 cycles) will be considered evaluable for response, unless documented progression occurred earlier. Safety profile Safety will be analysed in each treatment group. Patients having received > treatment doses are evaluable for toxicity. Evaluation will be performed by patient and by cycle on the intent-to-treat population. Clinical and laboratory toxicity/symptomatology will be graded according to NCI common criteria. The adverse events which are not reported in NCI common criteria will be graded as: mild, moderate, severe, life threatening. Statistical methodology The expected median survival in Arm A (standard arm) is 14 months. It is anticipated that the median survival in Arm B (experimental arm) will be 19 months. 620 patients (310 in each arm) are needed to show this increase in median survival (>=0,05 and >=0,80). Stratification parameters Patients will be stratified for the following parameters:
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Advanced Colorectal Cancer | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
820 | |||
Original Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | December 2006 | |||
Actual Primary Completion Date | February 2006 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Not Provided | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00312000 | |||
Other Study ID Numbers ICMJE | CAIRO1 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | C.J.A. Punt, MD PhD, DCCG | |||
Original Responsible Party | Not Provided | |||
Current Study Sponsor ICMJE | Dutch Colorectal Cancer Group | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Dutch Colorectal Cancer Group | |||
Verification Date | September 2008 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |