Regorafenib in Metastatic Colorectal Cancer : a Cohort Study in the Real-life Setting
NCT ID: NCT02310477
Last Updated: 2016-08-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
704 participants
OBSERVATIONAL
2014-02-28
2014-12-31
Brief Summary
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Detailed Description
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Patients were identified from the database of the French ATU (Temporary Authorization for Use), approved by the French Health Authorities to provide early access to innovative, not yet approved medicinal products such as REG.
Baseline patient and tumor characteristics, REG dosing and dose-intensity, REG-related adverse events, pre- and post REG treatments, predictors of events, and effectiveness data (PFS, OS) were collected from patients who agreed, and whom physicians accepted to collaborate on the REBECCA cohort.
Conditions
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Study Design
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COHORT
Interventions
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regorafenib
regorafenib for all groups
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* With a colorectal cancer metastatic histologically proven
* Have met the criteria defined in the monograph ATU (Temporary Authorization for Use) validated by French Health Authorities and for which the request for access to treatment has been validated, that is in patients with mCRC as used in clinical practice for mCRC who have been previously treated with, or are not considered candidates for, available therapies.
* Patients who received at least one dose on REG
* Patient deprived of liberty or under guardianship
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Centre Oscar Lambret
OTHER
Responsible Party
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Principal Investigators
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Antoine ADENIS, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Oscar Lambret
Locations
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Centre Oscar Lambret
Lille, , France
Countries
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References
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Adenis A, de la Fouchardiere C, Paule B, Burtin P, Tougeron D, Wallet J, Dourthe LM, Etienne PL, Mineur L, Clisant S, Phelip JM, Kramar A, Andre T. Survival, safety, and prognostic factors for outcome with Regorafenib in patients with metastatic colorectal cancer refractory to standard therapies: results from a multicenter study (REBECCA) nested within a compassionate use program. BMC Cancer. 2016 Jul 7;16:412. doi: 10.1186/s12885-016-2440-9.
Other Identifiers
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REBECCA-1305
Identifier Type: -
Identifier Source: org_study_id
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