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.

Eligibility Criteria:
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