Resource-Sparing Curative Treatment for Rectal Cancer

The use of a shortened fractionation schedule in the neoadjuvant (preoperative) treatment of rectal cancer has been popular in Europe since its introduction by a Swedish group in 1990.
This form of treatment is given in one week, thus providing convenience for the patients and resource-sparing for the treatment centres and has been widely tested in a number of European studies in resectable rectal cancer and more recently in unresectable rectal cancer as well, yielding encouraging results. However, this hypofractionated schedule has not been adopted in developing countries yet.
This CRP attempts to compare the short fractionation to a standard fractionation plus chemotherapy (the control arm) with the double aim of turning unresectable patients resectable (and thus increasing their chances of operability and cure) as well as make the participating centres familiar with this schedule and adopt it in their routine practice.
Therefore this is a prospective randomized phase III clinical trial comparing a short fractionation schedule of 25 Gy in 5 fractions over one week, to 50 Gy in 25 fractions over 5 weeks combined with chemotherapy as pre-operative treatment for locally advanced, unresectable rectal cancer. The use of pre-operative chemotherapy in the short fractionation arm of the study will be decided during the First Coordination Meeting.