Combination Chemotherapy and Radiation Therapy With/Without Surgery In Patients With Stage II/III Bladder Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

97

Participants

Timeline

Start Date

December 31, 2002

Primary Completion Date

October 31, 2010

Study Completion Date

May 14, 2018

Conditions
Bladder Cancer
Interventions
DRUG

cisplatin

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.

DRUG

fluorouracil

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.

DRUG

paclitaxel

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.

RADIATION

radiation therapy

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.

DRUG

Gemcitabine

Adjuvant: 1000 mg/m2 over 30-60 minutes on days 1 and 8 of each 21-day cycle for 4 cycles.

PROCEDURE

Radical cystectomy

Operable patients with pT1 or worse tumor response on re-evaluation following induction therapy will have radical cystectomy.

Trial Locations (2)

84103

LDS Hospital, Salt Lake City

84106

Utah Cancer Specialists at UCS Cancer Center, Salt Lake City

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

collaborator

Eastern Cooperative Oncology Group

NETWORK

collaborator

NRG Oncology

OTHER

lead

Radiation Therapy Oncology Group

NETWORK