RECORA- Regorafenib in patients with metastatic colorectal cancer (mCRC) after failure of standard therapy

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Effectiveness study (incl. comparative)
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  NEXAVAR
• Anatomical Therapeutic Chemical (ATC) code:
  (L01XE21) regorafenib

  regorafenib
• Medical condition to be studied:
  Colorectal cancer metastatic

Population studied

• Short description of the study population:
  Patients with metastatic colorectal carcinoma for whom the decision has been taken by the investigator to treat with Stivarga® as 3rd or 4th line treatment.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Colorectal cancer patients
• Estimated number of subjects:
  500

Study design details

• Main study objective:
  The primary objective of this study is the comparison of two cohorts of hepatocellular carcinoma patients regarding overall survival (OS) from time of TACE non-eligibility. The two cohorts of special interest are defined based on the investigators’ treatment decisions (i.e. patients with early start of Sorafenib treatment vs. patients without early start of Sorafenib treatment).
• Outcomes:
  Overall survival, Progression-free survivalTime to progressionDisease control rate (DCR)Duration of Stivarga treatmentTumor status at different visitsIncidence of treatment emergent adverse events (TEAE)
• Data analysis plan:
  In general, statistical analyses will be of explorative and descriptive nature. Analyses will be performed for the total study population (overall analysis) and separately for the two patient cohorts of special interest, as appropriate. The primary efficacy endpoint is Overall Survival (OS). It is defined in this study as the time period from documented TACE non-eligibility to death due to any cause. For the two cohorts of special interest, Kaplan-Meier (KM) estimates for OS will be displayed. Furthermore, these two cohorts will be compared regarding overall survival using a Cox proportional hazards model. Where applicable, the propensity score approach will be applied in order to compare the two cohorts.

Documents

Study results

16665_EU-PAS_Abstract

Study report

SV1313_16665_RECORA_OS report_EU PAS Register