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Completed

NCT Number: NCT02310477

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

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.

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Key information

Conditions

Metastatic Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Oscar Lambret

Lille, 59020, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

regorafenib

Drug

regorafenib for all groups

Other names: stivarga

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Oscar Lambret

Other

Collaborators

  • Bayer

Registry information

Official study title

REBECCA: A Cohort Study of Regorafenib in the Real-life Setting in Patients Previously Treated for Metastatic Colorectal Cancer.

Acronym: REBECCA

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Dec 8, 2014
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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