3-Dimensional Conformal Radiation Therapy in Treating Patients With Bladder Cancer Who Have Undergone Transurethral Resection of the Bladder
3-Dimensional Conformal Radiation Therapy in Treating Patients With Bladder Cancer Who Have Undergone Transurethral Resection of the Bladder
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized
 radiation therapy that delivers a high dose of radiation directly to the tumor may kill more
 tumor cells and cause less damage to normal tissue.

 PURPOSE: This phase I trial is studying the side effects and best dose of 3-dimensional
 conformal radiation therapy in treating patients with bladder cancer who have undergone
 transurethral resection of the bladder.
OBJECTIVES:

 Primary

 -  To determine the maximum-tolerated dose of external-beam radiotherapy delivered as a
 tumor boost in patients who have undergone prior transurethral bladder resection for
 muscle-invasive carcinoma of the bladder.

 Secondary

 -  To document progression-free survival and overall survival of these patients.

 -  To evaluate patterns of recurrence and bladder preservation rates following
 dose-escalated radiotherapy in these patients.

 -  To determine the impact of acute and late toxicity on quality of life in these patients.

 -  To assess the use of gold seeds for tumor boost delineation in these patients.

 -  To evaluate the use of virtual cystoscopy tumor localization in these patients.

 -  To assess coverage of the phase II radiotherapy boost volume on the daily cone-beam
 images.

 -  To assess coverage of the phase III radiotherapy volume on cone-beam images with
 selected adaptive strategy.

 -  To evaluate the use of diffusion-weighted MRI (dwMRI) scans in assessing response to
 radiotherapy.

 OUTLINE: This is a dose-escalation study.

 Patients undergo a rigid cystoscopy and gold-seed insertion, if clinically appropriate.
 Approximately 3-5 seeds are inserted into the bladder wall to demarcate the maximum extent of
 visible tumor or tumor bed via a customized introducer. All patients undergo 3-dimensional
 conformal radiotherapy once daily, 5 days per week during weeks 1 and 4-7 and once daily, 4-6
 days per week during weeks 2 and 3, using a combination of image-guided radiotherapy
 techniques and a partial bladder radiotherapy boost.

 Patients complete quality-of-life questionnaire QOL-30 at baseline, 1 and 3 months, and then
 annually after completion of study treatment.

 After completion of study treatment, patients are followed up at 4, 8, and 12 weeks, every 6
 months for 3 years, and then annually for 2 years.
DISEASE CHARACTERISTICS:

 -  Histologically confirmed invasive bladder carcinoma, including the following cellular
 types:

 -  Adenocarcinoma

 -  Transitional cell carcinoma

 -  Squamous cell carcinoma

 -  Clinical stage G1-3, pT2a-4 disease

 -  Localized disease

 -  No bone or visceral metastases

 -  No lymph node metastases

 -  Has undergone maximal transurethral resection of the bladder tumor and planning to
 receive radical radiotherapy

 PATIENT CHARACTERISTICS:

 -  WHO performance status 0-1

 -  Hemoglobin > 10 g/dL

 -  WBC > 3,000/mm^3

 -  Platelet count > 150,000/mm^3

 -  Creatinine < 120 μmol/L

 -  Bilirubin < 1.5 times upper limit normal (ULN)

 -  AST < 1.5 times ULN

 -  Alkaline phosphatase < 1.5 times ULN

 -  Not pregnant

 -  No inflammatory bowel disease or other significant small bowel disease

 -  Physically fit for radical radiotherapy

 -  No psychological, familial, sociological, or geographical condition potentially
 hampering compliance with the study protocol and follow-up schedule

 -  No other malignancy within the past 2 years except adequately treated basal cell
 carcinoma of the skin or adequately treated carcinoma in situ of the cervix uteri

 -  Prior superficial transitional cell carcinoma of the bladder allowed

 PRIOR CONCURRENT THERAPY:

 -  See Disease Characteristics

 -  No prior pelvic surgery

 -  No bilateral hip replacements compromising accurate radiotherapy planning

 -  No prior radiotherapy to the pelvis