Preoperative Hyperfractionated Radiotherapy Versus Combined Radiochemotherapy for Patients With Locally Advanced Rectal Cancer: a Phase III Randomized Trial.
Overview of randomized trials conducted in patients with advanced colorectal cancer with the
use of preoperative radiotherapy or radiochemotherapy clearly shows the superiority of
combined therapy over surgery alone. In these studies documented a significant reduction in
tumor mass as a result of preoperative radiotherapy or radiochemotherapy theoretically
increases the chance of performing operations with sphincters preservation, even in cases
originally eligible for abdomino - perineal resection. There is the question whether the
combination of preoperative hyperfractionated radiotherapy and concurrent chemotherapy may
cause the further improvement of treatment outcome in patients with locally advanced rectal
cancer. Published in 2012 by Gerard et al. meta-analysis of randomized trials dedicated to
the treatment of patients with advanced colorectal cancer, confirms a higher percentage of
sphincters preservation in patients operated after more than 5-week interval between
neoadjuvant therapy and surgery.
Analysis of these issues will be taken in the current study. Comparison of the two treatment
regimens as preoperative phase III study with stratification for time interval between the
end of radiotherapy or radiochemotherapy and surgery may show differences that have not been
seen in previously published data.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• The rate of patients with downstaging after radiotherapy or radiochemotherapy to pathological response or disease with negative margins
Surrogate endpoint available immediatly after surgery
Rafal Suwinski, MD
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch, Gliwice, Poland
Poland: Ethics Committee