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

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: NCT01959269
Recruitment Status : Completed
First Posted : October 9, 2013
Last Update Posted : March 8, 2018
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date October 8, 2013
First Posted Date October 9, 2013
Last Update Posted Date March 8, 2018
Actual Study Start Date October 31, 2013
Actual Primary Completion Date March 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 13, 2016)
Overall survival [ Time Frame: after 40 months ]
Original Primary Outcome Measures
 (submitted: October 8, 2013)
Overall survival [ Time Frame: after 36 months ]
Change History Complete list of historical versions of study NCT01959269 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: September 13, 2016)
  • Progression-free survival [ Time Frame: after 40 months ]
  • Time to progression [ Time Frame: after 40 months ]
  • 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).
  • 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)
  • 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.
  • 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.
Original Secondary Outcome Measures
 (submitted: October 8, 2013)
  • Progression-free survival [ Time Frame: after 36 months ]
  • Time to progression [ Time Frame: after 36 months ]
  • Disease control rate (DCR) [ Time Frame: after 36 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).
  • Duration of Stivarga treatment [ Time Frame: after 36 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)
  • Tumor status at different visits [ Time Frame: after 36 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.
  • Incidence of treatment emergent adverse events (TEAE) [ Time Frame: after 18 and 36 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Investigating the Use of Regorafenib (Stivarga®) in Patients With Metastatic Colorectal Cancer (mCRC) After Failure of Standard Therapy
Official Title RECORA- Regorafenib in Patients With Metastatic Colorectal Cancer (mCRC) After Failure of Standard Therapy.
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Female and male patients ≥ 18 years of age with a diagnosis of metastatic colorectal carcinoma (mCRC) will be enrolled in the sites during the enrollment period. All treatment decisions prior inclusion of a patient as well as during the observation must be made by the investigator based on his regular medical practice. Patients must give written informed consent prior to documentation.
Condition Colorectal Neoplasm
Intervention Drug: Regorafenib (Stivarga, BAY 73-4506)
As determined by the treating physician
Study Groups/Cohorts Regorafenib
Patients treated with Stivarga as 3rd or 4th line treatment, no intervention
Intervention: Drug: Regorafenib (Stivarga, BAY 73-4506)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 13, 2016)
483
Original Estimated Enrollment
 (submitted: October 8, 2013)
1000
Actual Study Completion Date July 7, 2017
Actual Primary Completion Date March 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:´

  • 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:

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT01959269
Other Study ID Numbers 16665
SV1313 ( Other Identifier: Company internal )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Bayer
Study Sponsor Bayer
Collaborators Not Provided
Investigators
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date March 2018