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OpenTrials
Completed

NCT Number: NCT01959269

Investigating the Use of Regorafenib (Stivarga®) in Patients With Metastatic Colorectal Cancer (mCRC) After Failure of Standard Therapy

The purpose of the study is to investigate the safety and effectiveness of Stivarga in patients with metastatic colorectal carcinoma in routine use in Germany. The study is purely observational, only data from routine treatment are to be collected. The treatment and treatment conditions are solely at discretion of the treating physician.

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Key information

Conditions

Colorectal Neoplasm 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

Multiple Locations, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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  • Male or female patients ≥ 18 years of age with metastatic CRC for whom the decision has been taken by the investigator to treat with Stivarga.
  • Patients must have signed an informed consent form

Exclusion criteria

Treatment and study plan

Regorafenib (Stivarga, BAY 73-4506)

Drug

As determined by the treating physician

Primary outcomes

  1. Overall survival

    Time frame: after 40 months

Secondary outcomes

  1. Progression-free survival

    Time frame: after 40 months

  2. Time to progression

    Time frame: after 40 months

  3. Disease control rate (DCR)

    Time frame: after 40 months

    Disease control rate (DCR) is defined as percentage of patients, whose best response was not progressive disease (i.e. complete response, partial response or stable disease).

  4. Duration of Stivarga treatment

    Time frame: after 40 months

    Duration of Stivarga treatment is defined as the time interval from start of Stivarga therapy to the date of permanent discontinuation of Stivarga therapy (regardless of the reason for discontinuation)

  5. Tumor status at different visits

    Time frame: after 40 months

    The tumor status at different visits will be evaluated according to the categories "complete response", "partial response", "stable disease", "progressive disease by clinical judgment", "progressive disease measurement proven", "unknown" and "not applicable". The best overall response will be analyzed providing absolute and relative frequencies of the tumor status categories.

  6. Incidence of treatment emergent adverse events (TEAE)

    Time frame: after 18 and 40 months

    Detailed information collected for each TEAE will include: a description of the event, duration, whether the TEAE was serious, relationship to Stivarga, action taken, clinical outcome. Summary tables will present the number of subjects observed with TEAEs and corresponding percentages. Additional subcategories will be based on event intensity and relationship to study drug.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

RECORA- Regorafenib in Patients With Metastatic Colorectal Cancer (mCRC) After Failure of Standard Therapy.

Acronym: RECORA

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Oct 9, 2013
Registry last updated
Mar 8, 2018

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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