NCT01124682

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

Image Guided Dose Escalated Adaptive Bladder Radiotherapy

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Institute of Cancer Research, United Kingdom · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bladder Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2009-05-01
• Primary completion: 2016-04-01
• First posted: 2010-05-17
• Last updated: 2013-08-26

Locations

1 site across 1 country: United Kingdom