Background: This prospective, phase III study aimed at evaluation the efficacy and toxicity of hypofractionated
radiation schedule versus conventional radiation given concurrent with weekly Gemcitabine.
Patient and methods: Fifty one patients with transitional cell carcinoma, stage T1-4a, N0, M0 after transurethral
resection [TUR] and magnetic resonance imaging, were recruited. Patients were categorized into two groups: 33
patients [in Group A] who were treated with hypofractionated radiotherapy [RT] schedule that delivered 52.5 Gy in
20 fractions and 18 patients [in Group B] who were treated with conventional RT schedule 64 Gy in 32 fractions.
Both groups received weekly Gemcitabine 100mg/m².
Results: the majority of patients achieved complete response (CR); in group A (81.8%) and in group B (66.7%).
There were significant difference between the two study groups regarding 2 year overall survival [OS] rate (88.2%
vs 75.6% in group A& B respectively, P= 0.049) and relapse free survival [RFS] (66.6% vs 56.7% in group A& B
respectively with P =0.033) in favor of group A. There were significant difference between the two study groups, in
favor of group A, regarding cystitis (P= 0.038) and enteritis (P ˂0.001).
Conclusion: The hypofractionated radiation proved to be of higher CR rate and survival rate with the favorable
toxicity profile than that of conventionally fractionated radiation schedule given concurrently with Gemcitabine.