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

NCT02310477 | Completed DMC

• 1 other identifier: REBECCA-1305
• Study Type: observational
• Target: 704
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Colorectal Cancer

Keywords

regorafenib, cohort, metastatic colorectal cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

  median time between the date of the first administration REG and the date of the death

  at death or at the end of study

Secondary Outcomes (6)

• Patients and tumor baseline characteristics

  at the end of treatment

• Time under REG treatment

  at the end of treatment

• Compliance

  at the end of study

• Safety of REG

  at the end of treatment

• Potential predictive factors

  at the end of study

Interventions

regorafenib DRUG

regorafenib for all groups

Also known as: stivarga

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Opposed to the study
• Patient deprived of liberty or under guardianship

Sponsors & Collaborators

• Centre Oscar Lambret: lead
• Bayer: collaborator

Study Sites (1)

Centre Oscar Lambret

Lille, 59020, France

Location

Related Publications (1)

• 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.

  PMID: 27389564 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

regorafenib

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Antoine ADENIS, MD

  Centre Oscar Lambret

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2014
• First Posted: December 8, 2014
• Study Start: February 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)