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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Image Guided Dose Escalated Adaptive Bladder Radiotherapy

Conditions
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Bladder Cancer

Intervention / Treatment
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* Procedure: diagnostic cystoscopy
* Procedure: diffusion-weighted magnetic resonance imaging
* Procedure: implanted fiducial-based imaging
* Procedure: quality-of-life assessment
* Radiation: 3-dimensional conformal radiation therapy
* Radiation: image-guided radiation therapy
* Radiation: selective external radiation therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: diagnostic cystoscopy|nan|
|Procedure: diffusion-weighted magnetic resonance imaging|nan|
|Procedure: implanted fiducial-based imaging|nan|
|Procedure: quality-of-life assessment|nan|
|Radiation: 3-dimensional conformal radiation therapy|nan|
|Radiation: image-guided radiation therapy|nan|
|Radiation: selective external radiation therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum-tolerated dose |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  |  | 
| Overall survival |  |  | 
| Bladder preservation rates |  |  | 
| Acute and late toxicity and safety profile |  |  | 
| Quality of life |  |  | 
| Tumor boost volumes delineated with and without gold seeds |  |  | 
| Dose-volume histogram analysis of PTV2 and PTV3 coverage |  |  | 
| Change in diffusion coefficient between pre- and post-radiotherapy dwMRI scans |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adenocarcinoma of the bladder, squamous cell carcinoma of the bladder, transitional cell carcinoma of the bladder, recurrent bladder cancer, stage II bladder cancer, stage III bladder cancer, stage IV bladder cancer