Maintenance Treatment Versus Observation After Induction in Advanced Colorectal Carcinoma (CAIRO3)
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ClinicalTrials.gov Identifier: NCT00442637 |
Recruitment Status : Unknown
Verified December 2013 by Dutch Colorectal Cancer Group.
Recruitment status was: Active, not recruiting
First Posted : March 2, 2007
Last Update Posted : December 12, 2013
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Tracking Information | ||||
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First Submitted Date ICMJE | February 28, 2007 | |||
First Posted Date ICMJE | March 2, 2007 | |||
Last Update Posted Date | December 12, 2013 | |||
Study Start Date ICMJE | January 2007 | |||
Actual Primary Completion Date | September 2013 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Progression-free survival after re-introduction of MTD chemotherapy and bevacizumab (PFS2) [ Time Frame: study duration ] | |||
Original Primary Outcome Measures ICMJE |
Progression-free survival after re-introduction of MTD chemotherapy and bevacizumab (PFS2) | |||
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 | Maintenance Treatment Versus Observation After Induction in Advanced Colorectal Carcinoma | |||
Official Title ICMJE | Maintenance Treatment With Capecitabine and Bevacizumab Versus Observation After Induction Treatment With Chemotherapy and Bevacizumab as First-line Treatment in Patients With Advanced Colorectal Carcinoma | |||
Brief Summary | The optimal duration of systemic treatment in patients with advanced colorectal cancer is unknown. In this study the effects of bevacizumab and low-dose continuous chemotherapy with capecitabine is investigated in patients who have responded to 6 courses of oxaliplatin, capecitabine and bevacizumab ("induction treatment", at standard doses). This treatment is continued until progression or severe toxicity. This regimen is compared to the effects a observation without treatment after the induction treatment. In case of disease progression, induction treatment will be reintroduced. |
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Detailed Description | Standard 1st-line treatment for patients with advanced colorectal cancer currently consists of chemotherapy plus bevacizumab. With this approach the median overall survival is approximately 20 months, and progression-free survival in first-line approximately 9-11 months. The optimal duration of treatment is unknown. Current data suggest that the efficacy of bevacizumab is dependent on concomitant use of chemotherapy. However, oxaliplatin almost invariably gives rise to neuropathy after 6-8 cycles. Prolonged use of capecitabine is associated with e.g. hand-foot syndrome. Lastly, the prolonged use of these agents is associated with considerable costs. Evidence, mainly preclinical, suggests that continuous dosing metronomic chemotherapy may be more efficacious than interval-chemotherapy given at MTD. In this study the concept of metronomic chemotherapy is explored by administering a continuous daily instead of the usual 2 weeks-on/1 week-off oral dosing regimen of low-dose capecitabine plus bevacizumab as maintenance therapy after induction combination chemotherapy given at MTD plus bevacizumab. |
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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 | Colorectal Cancer Metastatic | |||
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 | Unknown status | |||
Estimated Enrollment ICMJE |
635 | |||
Original Enrollment ICMJE | Same as current | |||
Estimated Study Completion Date ICMJE | December 2013 | |||
Actual Primary Completion Date | September 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Before the start of induction therapy: Inclusion Criteria:
Exclusion criteria
At randomisation: Inclusion 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 | Netherlands | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00442637 | |||
Other Study ID Numbers ICMJE | CAIRO3 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Dutch Colorectal Cancer Group | |||
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 | December 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |