Organ Preservation in Locally Advanced Rectal Cancer by Radiochemotherapy Followed by Consolidation Chemotherapy.
Status:
Recruiting
Trial end date:
2024-04-16
Target enrollment:
Participant gender:
Summary
There is a growing body of evidence that surgery and associated morbidities can be omitted
without compromising oncological safety in selected patients who have achieved a clinical
complete response after radiochemotherapy. However with standard neoadjuvant treatment
regimens the pathological complete response rate lies in the range between 10%-20%, the
number of patients qualifying for non-operative management is even lower since the
sensitivity of currently available diagnostic measures for predicting the pathological
complete response hardly surpasses 50%-60%.The hereby proposed phase II trial CAO/ARO/AIO-16
aims at finding novel and innovative aspects of rectal cancer treatment. According to
recently published data the radiochemotherapy regime in the present study with consolidating
chemotherapy and delayed assessment of response has the potential to achieve pathological
complete rates of approximately 40%. A standardized re-evaluation after consolidating
chemotherapy will select patients who are candidates for organ-preservation. These patients
will not undergo radical surgery and will instead be follow-up closely for tumor regrowth.