Clinical Trials

print version

ICORG opens ANGIOPREDICT study in Ireland and Germany

 

WHAT IS ANGIOPREDICT?

The ANGIOPREDICT prospective translational study is an Exploratory Phase II clinical trial comprising biomarker analysis of oxaliplatin plus fluorouracil/leucovorin (FOLFOX) in combination with bevacizumab (bvz) in first line treatment of metastatic colorectal cancer (CRC) expressing mutant K-ras – AC-ANGIOPREDICT'.

WHO CAN PARTICIPATE?

Patients with locally advanced or metastatic colorectal cancer expressing mutant K-ras are eligible for this study. Patients will undergo standard therapy with FOLFOX in combination with bevacizumab and biological samples (blood, fresh and formalin fixed tissue) will be collected at various time points before, during and after the therapy. The enrolment target is 224 patients. The primary objective is to validate predictive/prognostic genomic DNA and expression biomarkers of response to combination bvz treatments, which have been identified previously in archival tissue.

ABOUT ICORG

ICORG, The All-Ireland Cooperative Oncology Research Group (www.icorg.ie) is an investigator run, not-for-profit oncology clinical trials organisation. ICORG's mission is to get patients early access to the latest cancer treatments through research and to gain a reputation for Ireland as a recognised centre of high quality translational and clinical research in Ireland. Today 97% of the Islands cancer treating consultants are ICORG members ensuring that research into cancer is at a national level. Since 1997 ICORG has opened 260 research protocols allowing access to more than 30 different research treatments in multiple disease areas. Today over 4,050 patients are currently on trial on 113 active studies. ICORG has developed strong links with many leading international cancer research groups such as ECOG-ACRIN, NSABP (now NRG), TRIO and CRUK and many of those in industry developing the most promising new cancer treatments. 

ICORGs Position in the ANGIOPREDICT CONSORTIUM

ICORG is a partner in the EU FP7 funded Angiopredict initiative (www.angiopredict.com) led by the Royal College of Surgeons in Ireland, andis responsible for the coordination of all clinical aspects of the ANGIOPREDICT study and establishment of the ANGIOPREDICT Bioresource. Biological samples collected through the prospective trial and retrospective samples made available by consortium members are stored in the ANGIOPREDICT Bioresource, which is based at the University Hospital Mannheim in Germany. ICORG developed the ANGIOPREDICT study protocol and Standard Operating Procedures (SOP) for sample collection together with the two Chief Investigators; Prof. Matthias Ebert from the University Hospital Mannheim, Germany, and Prof Seamus O'Reilly from Cork University Hospital, Ireland. ICORG in collaboration with the Mannheimer Arbeitsgruppe Gastrointestinale Tumoren (MARGIT) act as sponsor for the prospective trial in Germany and oversees the smooth running of the trial. Clinical data are collected using an electronic data capture (EDC) tool developed and tailored by ICORG Data Management. 

To date the ANGIOPREDICT trial has been opened in 7 of 9 participating cancer centers in Ireland, and in 3 of 9 participating cancer centers in Germany. The remaining centers will be initiated in the coming months. ICORG provides study material and protocol training to each site at opening. The first patient in Ireland has been recruited by St. Vincent's University Hospital, Dublin. The patient donated blood, fresh and formalin fixed tissue to the ANGIOPREDICT Bioresource.