Patient case: 64-year-old male with bladder cancer; genetic feature: FGFR3 (S249C)

Clinical trial: 3-Dimensional Conformal Radiation Therapy in Treating Patients With Bladder Cancer Who Have Undergone Transurethral Resection of the Bladder

Summary: 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.

Detailed description: 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: 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

Relevance to patient case: not relevant