Phase III Clinical Trial OPERA starts
The Organ Preservation of Early Rectal Adenocarcinoma (OPERA) phase III trial has started to recruit patients at the Centre Antoine-Lacassagne in Nice, France. This Pan-European trial, developed by Prof Jean-Pierre Gerard (Nice) and Prof Arthur Sun Myint (Clatterbridge, UK) is looking to recruit patients across existing Papillon users in France, UK, Sweden, Denmark and Switzerland as well as driving interest in new territories.
The 3 year trial aims to evaluate, using the Ariane Papillon treatment system, in conjunction with neoadjuvant chemoradiotherapy, a radiation dose escalation using 2 different approaches: External Beam Radiation Therapy versus endocavitary Radiation Therapy with Contact X-ray Brachytherapy 50 kV for patients with rectal adenocarcinoma cT2-T3 a,b < 5cm in diameter in distal and middle rectum. With the endpoint being organ preservation at 3 years without non-salvageable local pelvic recurrence. The proof of this concept will be of most benefit for all patients but especially for the elderly who usually are not fit for or keen to undergo major surgery. For further details please contact Ariane medical and/or download the protocols from this site.