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Regorafenib in Metastatic Colorectal Cancer : a Cohort Study in the Real-life Setting (REBECCA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02310477
Recruitment Status : Completed
First Posted : December 8, 2014
Last Update Posted : August 9, 2016
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Centre Oscar Lambret

Brief Summary:
This is a largest cohort study aimed to estimate the overall survival of patients been treated with regorafenib for metastatic colorectal cancer (mCRC) within the frame of a french compassionate program.

Condition or disease Intervention/treatment
Metastatic Colorectal Cancer Drug: regorafenib

Detailed Description:

Regorafenib (REG) is a multi-kinase inhibitor with survival benefits in patients with pretreated mCRC, as demonstrated in the phase III CORRECT study. As a result, REG has been made available for medical practice use in the US, and in the Europe. However, prescribing conditions in the real-life setting are known to be less stringent than selection criteria in clinical trials. The REgorafeniB in mEtastatic Colorectal cancer: a French Compassionate progrAm (REBECCA) is an ambispective cohort study designed to elucidate safety and effectiveness outcomes associated with REG as used in clinical practice for mCRC who have been previously treated with, or are not considered candidates for, available therapies.

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.

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Study Type : Observational
Actual Enrollment : 704 participants
Observational Model: Cohort
Official Title: REBECCA: A Cohort Study of Regorafenib in the Real-life Setting in Patients Previously Treated for Metastatic Colorectal Cancer.
Study Start Date : February 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Regorafenib


Intervention Details:
  • Drug: regorafenib
    regorafenib for all groups
    Other Name: stivarga


Primary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: at death or at the end of study ]
    median time between the date of the first administration REG and the date of the death


Secondary Outcome Measures :
  1. Patients and tumor baseline characteristics [ Time Frame: at the end of treatment ]
    Tumor location, KRAS status, synchronous or metachronus metastases, time elapsed from diagnosis of metastases, surgery of the primary, previous times of treatment, weight/height/BMI, ECOG, met location, age, performance status

  2. Time under REG treatment [ Time Frame: at the end of treatment ]
    calculated from the start of treatment until the treatment discontinuation for any cause) and within some subgroups of patients:Tumor location, KRAS status, synchronous or metachronus metastases, time elapsed from diagnosis of metastases, surgery of the primary, previous times of treatment, weight/height/BMI, ECOG, met location, age, performance status, initial REG dosage

  3. Compliance [ Time Frame: at the end of study ]
    dose-intensity of treatment with REG, including the actual daily dosage

  4. Safety of REG [ Time Frame: at the end of treatment ]
    according to NCI-CTCAE (Common Toxicity Criteria for Adverse Effects) v4.0 and within some subgroups of patients

  5. Potential predictive factors [ Time Frame: at the end of study ]
    regarding tolerance, time under REG treatment, PFS, and OS.

  6. Progression-free survival (PFS) [ Time Frame: at the end of study ]
    median time between the date of the first administration REG and the date of the first progression



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

elligible patients were those who accepted to participate to the cohort study, and whom physicians accepted to collaborate on the REBECCA cohort.

Criteria

Inclusion criteria :

  • Patient ≥ 18 years old
  • 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

Exclusion criteria :

  • Opposed to the study
  • Patient does not meet the inclusion criteria
  • Patient deprived of liberty or under guardianship

Information from the National Library of Medicine

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): NCT02310477


Locations
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France
Centre Oscar Lambret
Lille, France, 59020
Sponsors and Collaborators
Centre Oscar Lambret
Bayer
Investigators
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Principal Investigator: Antoine ADENIS, MD Centre Oscar Lambret
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT02310477    
Other Study ID Numbers: REBECCA-1305
First Posted: December 8, 2014    Key Record Dates
Last Update Posted: August 9, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Centre Oscar Lambret:
regorafenib, cohort, metastatic colorectal cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases