Study: NCT00777491

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Induction QD radiation therapy
Description: Once daily (QD) on days (1-5,8-12,15-19,22-26). For the first 10 treatment days, 2 Gy is delivered to the pelvis. Then, 2 Gy is delivered to the bladder for the next 4 treatment days, followed by 2 Gy to the bladder tumor volume for the remaining 6 treatment days. The bladder tumor volume receives a total of 40 Gy.

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Consolidation BID radiation therapy
Description: Twice daily (BID) for 8 days on days 1,2,3,4,5,8,9,10 of consolidation. 1.5 Gy per fraction for a total of 24 Gy delivered to the pelvis.

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Consolidation QD radiation therapy
Description: Once daily (QD) pelvic radiation therapy for 12 days on days 1-5,8-12,15-16 of consolidation. 2 Gy per fraction for a total of 24 Gy delivered to the pelvis.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: consolidation gemcitabine
Description: 27 mg/m\^2 administered as a 30-minute infusion on days 1, 4, 8, 11, 15 of consolidation.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: consolidation 5-fluorouracil
Description: 400 mg/m\^2 administered as a 24-hour infusion on days 1, 2, 3 and 8, 9, 10 of consolidation.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: consolidation cisplatin
Description: 15 mg/m\^2 administered as a sixty-minute infusion on days 1, 2, 8, 9 of consolidation.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: radical cystectomy
Description: Operable patients who have a pT1 or worse tumor response on re-evaluation following initial transurethral resection and induction chemoradiotherapy will have a radical cystectomy 3-8 weeks following the post-induction response evaluation.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: radical cystectomy
Description: Operable patients who have a pT1 or worse tumor response on re-evaluation following initial transurethral resection and induction chemoradiotherapy will have a radical cystectomy 3-8 weeks following the post-induction response evaluation.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Post-Induction Chemoradiotherapy Endoscopic Response Evaluation
Description: Urine cytology, cystoscopy, tumor site transurethral biopsy, and bimanual examination after biopsy.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Post-Induction Chemoradiotherapy Endoscopic Response Evaluation
Description: Urine cytology, cystoscopy, tumor site transurethral biopsy, and bimanual examination after biopsy.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: adjuvant gemcitabine
Description: 1000 mg/m\^2 administered intravenously over 30-60 minutes (preferably 30 minutes) on days 1 and 8 of each 21-day cycle for four cycles.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: adjuvant gemcitabine
Description: 1000 mg/m\^2 administered intravenously over 30-60 minutes (preferably 30 minutes) on days 1 and 8 of each 21-day cycle for four cycles.