P-304 - RECORA - A national non-interventional study to assess efficacy and safety of regorafenib in patients with metastatic colorectal cancer (mCRC) after...

Date 04 July 2015
Event WorldGI 2015
Session Posters
Topics Anti-Cancer Agents & Biologic Therapy
Colon Cancer
Rectal Cancer
Presenter C. Bokemeyer
Citation Annals of Oncology (2015) 26 (suppl_4): 1-100. 10.1093/annonc/mdv233
Authors C. Bokemeyer1, H. Schulz2, J. Janssen3, U. Scheuring1, M. Langen1
  • 1University Hospital Hamburg, Hamburg-Eppendorf/DE
  • 2Praxis Internistischer Onkologie und Hämatologie (pioh) Frechen, Frechen/DE
  • 3Medizinische Studiengesellschaft NORD-WEST GmbH, Westerstede/DE



To date regorafenib is the only oral multikinase inhibitor as monotherapy that has demonstrated the ability to improve overall survival of patients with standardly pretreated advanced refractory colorectal cancer in 2 phase III studies (CORRECT and CONCUR). Regorafenib is indicated for the treatment of patients who have been previously treated with, or are not considered candidates for, fluoropyrimidine-based chemotherapy, an anti-VEGF therapy, and an anti-EGFR therapy. Unlike in the phase III trials, patients receiving regorafenib in real-life treatment are usually more heterogeneous with various comorbid conditions. Therefore, the aim of this non-interventional study is to characterize the efficacy and safety of regorafenib under routine daily practice conditions.


RECORA is a national, prospective, open-label, multi-center, single arm cohort non-interventional post-authorization safety study. Metastatic colorectal cancer patients are eligible if ≥ 18 years of age and if the decision has been taken by the investigator to treat them with regorafenib as 3rd or 4th line treatment. The decision to treat with regorafenib is made by the physician prior to enrollment. Patient data are collected during visits according to local clinical practice. The primary objective is to investigate overall survival. Secondary objectives include determining progression free survival, time to progression, disease control rate, duration of regorafenib treatment, tumor status at different visits and the incidence of treatment emergent adverse events. It is planned to enroll 500 patients at 100 sites in Germany. One interim analysis of the baseline and safety data will be performed approximately 1.5 years after start of study. Final analysis will be performed once the last enrolled patient has been observed for 12 months, or at any time due to premature discontinuation of the last patient's observation. The study started in October 2013. 277 patients have been enrolled in 83 sites as of February 2015. Clinical trial information: NCT01959269.