A Phase II Protocol for Patients With Stage T1 Bladder Cancer to Evaluate Selective Bladder Preserving Treatment by Radiation Therapy Concurrent With Radiosensitizing Chemotherapy Following a Thorough Transurethral Surgical Re-Staging

Status: 
Recruiting
Clinicaltrials.gov identifier: 
NCT00981656
Sponsor: 
Radiation Therapy Oncology Group (RTOG)
Enrollment: 
37
Study Design: 
This is a single arm study treating patients with TURBT and then concurrent radiation therapy and chemotherapy. The chemotherapy regimen consists of either cisplatin or mitomycin plus fluorouracil, similar to that used by the MRC for locally advanced bladder cancer [1]. Eligibility is limited to patients with recurrent Ta or T1 high grade tumor after BCG therapy or patients in whom BCG is contra-indicated or patients that refuse BCG therapy. [1] James ND et al N Engl J Med (2012) Apr 19;366: (16):1477–88.
Rationale: 
Radiation combined with radiation-sensitizing chemotherapy has been effective in well-selected muscle-invasive bladder cancer patients. However, options for T1 bladder cancer refractory to BCG are limited and include radical cystectomy or experimental therapies. This trial applies trimodal therapy to T1 bladder cancer patients in the hope of sparing their bladders and effectively treating their disease.
Endpoints: 
The primary endpoint is the rate of freedom from radical cystectomy at 3 years. Secondary endpoints include: rate of freedom from radical cystectomy at 5 years, rate of freedom from the development of distant disease progression at 3 and 5 years, rate of freedom from progression of bladder tumor to stage T2 or greater at 3 and 5 years, disease-specific survival, overall survival, incidence of acute and late pelvic toxicity, recurrence of any local bladder tumor, potential prognostic value of tumor histopathology, molecular genetics, DNA content, and urine proteomics and the American Urological Association symptom scores at baseline and at 3 years.
Comments: 
BCG-refractory T1 bladder cancer can be quite aggressive and normally these patients are counseled to undergo radical cystectomy. This clinical trial presents a bladder-sparing option to these patients. This trial is nearing the end of its accrual and the results may establish a new standard of therapy. However, patient selection will be key as it is for chemoradiotherapy for muscle-invasive disease and patients without hydronephrosis, CIS, or variant histology are excluded from this trial. Importantly, patients require a radical and complete TUR for inclusion into this trial.