3-Dimensional Conformal Radiation Therapy in Treating Patients With Bladder Cancer Who Have Undergone Transurethral Resection of the Bladder
- Conditions
- Bladder Cancer
- Registration Number
- NCT01124682
- Lead Sponsor
- Institute of Cancer Research, United Kingdom
- Brief 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Maximum-tolerated dose
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Royal Marsden - Surrey
🇬🇧Sutton, England, United Kingdom