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.
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
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Image Guided Dose Escalated Adaptive Bladder Radiotherapy|
- Maximum-tolerated dose [ Designated as safety issue: No ]
- Progression-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Bladder preservation rates [ Designated as safety issue: No ]
- Acute and late toxicity and safety profile [ Designated as safety issue: Yes ]
- Quality of life [ Designated as safety issue: No ]
- Tumor boost volumes delineated with and without gold seeds [ Designated as safety issue: No ]
- Dose-volume histogram analysis of PTV2 and PTV3 coverage [ Designated as safety issue: No ]
- Change in diffusion coefficient between pre- and post-radiotherapy dwMRI scans [ Designated as safety issue: No ]
|Study Start Date:||May 2009|
|Estimated Primary Completion Date:||April 2016 (Final data collection date for primary outcome measure)|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01124682
|Royal Marsden - Surrey||Recruiting|
|Sutton, England, United Kingdom, SM2 5PT|
|Contact: Contact Person 44-20-8661-3457 firstname.lastname@example.org|
|Principal Investigator:||Robert A. Huddart, MD||Royal Marsden NHS Foundation Trust|