Trial Information

Image Guided Dose Escalated Adaptive Bladder Radiotherapy

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.