A phase I—II study of synchronous chemoradiotherapy for poor prognosis locally advanced bladder cancer

Background: The management of locally advanced bladder cancer remains controversial with poor local control with radiotherapy alone. Synchronous chemotherapy regimens have yielded encouraging results in other primary sites. Patients and methods: Patients with T2–T4a N0/NX M0 bladder cancer were entered into this single centre phase I—II study. Patients received radiotherapy to 55 Gy in 20 fractions over four weeks. Concurrent chemotherapy was given with Mitomycin C 12 mg/m2 day 1 and 5-fluorouracil 500 mg/m2/24 hours weeks one and four of radiotherapy for five or seven days on each occasion. Results: Thirty-one patients entered the trial from March 1998 to December 1999 (22: 5-day; 9: 7-day schedule). Median age was 68 (range 58–79) years, 23 males and 8 females; T2: 9 (29%); T3a: 4 (12%); T3b: 9 (29%); 14: 9 (29%); TCC grade 2:8 (26%) and grade 3: 23 (74%); 14 of 31 had hydronephrosis. Ten of thirty-one had a GFR