Study: NCT00055601

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: cisplatin
Description: Induction: 15 mg/m2 as a 60-minute infusion on days 1, 2, 3, 8, 9, 10, 15, 16, and 17; Consolidation: 15 mg/m2 as a 60-minute infusion on days 1, 2, 8, and 9; Adjuvant: 35 mg/m2 as a 60-minute infusion on days 1 and 8 of each 21-day cycle for 4 cycles.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: cisplatin
Description: Induction: 15 mg/m2 as a 60-minute infusion on days 1, 2, 3, 8, 9, 10, 15, 16, and 17; Consolidation: 15 mg/m2 as a 60-minute infusion on days 1, 2, 8, and 9; Adjuvant: 35 mg/m2 as a 60-minute infusion on days 1 and 8 of each 21-day cycle for 4 cycles.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: fluorouracil
Description: Induction: 400 mg/m2 as a 24-hour infusion on days 1, 2, 3, 15, 16, and 17; Consolidation: 400 mg/m2 as a 24-hour infusion on days 1, 2, 3, 8, 9, and 10.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: paclitaxel
Description: Induction: 50 mg/m2 as a 60-minute infusion on days 1, 8, and 15; Consolidation: 50 mg/m2 as a 60-minute infusion on days 1 and 8; Adjuvant: 50 mg/m2 as a 60-minute infusion on days 1 and 8 of each 21-day cycle for 4 cycles.

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: radiation therapy
Description: Induction: External beam irradiation, 1.6 Gy, will be given to the pelvis in the first treatment followed by an interfraction period of at least 4-6 hours. During the second treatment, 1.5 Gy will be delivered to the whole bladder for the first five sessions (7.5 Gy) then to the tumor plus a margin for eight sessions (12. Gy). Consolidation: Consolidation therapy will start 7-14 days following a cystoscopic re-evaluation demonstrating a complete response to the induction therapy. 1.5 Gy (per fraction) will be given to the pelvis in two treatment fractions per day, with an interfraction period of at least 4-6 hours.

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: radiation therapy
Description: Induction: External beam irradiation, 1.6 Gy, will be given to the pelvis in the first treatment followed by an interfraction period of at least 4-6 hours. During the second treatment, 1.5 Gy will be delivered to the whole bladder for the first five sessions (7.5 Gy) then to the tumor plus a margin for eight sessions (12. Gy). Consolidation: Consolidation therapy will start 7-14 days following a cystoscopic re-evaluation demonstrating a complete response to the induction therapy. 1.5 Gy (per fraction) will be given to the pelvis in two treatment fractions per day, with an interfraction period of at least 4-6 hours.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Gemcitabine
Description: Adjuvant: 1000 mg/m2 over 30-60 minutes on days 1 and 8 of each 21-day cycle for 4 cycles.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Gemcitabine
Description: Adjuvant: 1000 mg/m2 over 30-60 minutes on days 1 and 8 of each 21-day cycle for 4 cycles.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Radical cystectomy
Description: Operable patients with pT1 or worse tumor response on re-evaluation following induction therapy will have radical cystectomy.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Radical cystectomy
Description: Operable patients with pT1 or worse tumor response on re-evaluation following induction therapy will have radical cystectomy.