3-Dimensional Conformal Radiation Therapy in Treating Patients With Bladder Cancer Who Have Undergone Transurethral Resection of the Bladder
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|ClinicalTrials.gov Identifier: NCT01124682|
Recruitment Status : Unknown
Verified February 2011 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : May 17, 2010
Last Update Posted : August 26, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer||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||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Masking:||None (Open Label)|
|Official Title:||Image Guided Dose Escalated Adaptive Bladder Radiotherapy|
|Study Start Date :||May 2009|
|Estimated Primary Completion Date :||April 2016|
- Maximum-tolerated dose
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01124682
|Royal Marsden - Surrey||Recruiting|
|Sutton, England, United Kingdom, SM2 5PT|
|Contact: Contact Person 44-20-8661-3457 email@example.com|
|Principal Investigator:||Robert A. Huddart, MD||Royal Marsden NHS Foundation Trust|