Adult Clinical Trials: Bladder

RTOG 0233:  BLADDER

A Phase II Randomized Trial For Patients With Muscle-Invading Bladder Cancer Evaluating Transurethral Surgery And BID Irradiation Plus Either Paclitaxel And Cisplatin Or 5-Fluorouracil And Cisplatin Followed By Selective Bladder Preservation And Gemcitabine/Paclitaxel/Cisplatin Adjuvant Chemotherapy

• Operable patients with muscularis propria invasion carcinoma of the bladder, all histologies; AJCC Stages T2-T4a, NX or N0, M0; No histologic evidence of tumor invasion into the stroma of the prostate
• No tumor-related hydronephrosis
• No node metastases
• Adequately functioning bladder; Patients must have undergone as thorough a transurethral resection of the bladder tumor as is judged safely possible
• Treatment must begin within 8 weeks following TUR
• Patients must be considered able to tolerate systemic chemotherapy, pelvic radiation therapy, and a radical cystectomy
• No prior systemic chemotherapy or pelvic RT
• No concurrent drugs that have potential nephrotoxicity or otoxicity
• No prior or concurrent malignancy (except stage T1a prostate cancer, carcinoma in situ of the uterine cervix, or non-melanoma skin cancer) unless disease free for > 5 years

Treatment

Induction Chemoradiotherapy starts within 8 weeks post TUR, Weeks 1-3:
Arm 1: paclitaxel, cisplatin, and BID irradiation
Arm 2: 5FU, cisplatin, and BID irradiation

Post-Induction Response Evaluation; Consolidation Chemoradiotherapy or Radical Cystectomy
Tumor Response; Consolidation Chemoradiotherapy, Weeks 8-9 for T0, Ta, Tcis:
Arm 1: paclitaxel, cisplatin, BID irradiation
Arm 2: 5FU, cisplatin, BID irradiation

For> T1: Radical Cystectomy, Week 9
Adjuvant Chemotherapy