Resource-Sparing Curative Treatment for Rectal Cancer
Closed for proposals
Project Type
Project Code
E33034CRP
1524Approved Date
Status
Start Date
Expected End Date
Completed Date
26 November 2015Description
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.
Objectives
The primary end point of this study is resectability. This is a short-term outcome which is
influenced directly by neo-adjuvant treatments. Secondary endpoints include survival, changes
in CEA, pathological findings at surgery, acute and delayed toxicities, and rates of pelvic control
of cancer. Although neo-adjuvant treatments may influence many of these secondary
outcomes, some may be less influenced by neo-adjuvant treatments, and such influence may
be indirect.
Specific objectives
Resectability
R0 (negative margins) resectability
Overall survival
Biological effects of treatment
Quality of Life
Economic impact
Impact
The CRP potentially has high impact in our MS where radiotherapy resources are inadequate. Use of a short fractionation may allow more patients initially deemed inoperable to receive radical treatment in a timely fashion and proceed to curative surgery.
Relevance
Highly relevant in IAEA MS