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Image Guided Dose Escalated Adaptive Bladder Radiotherapy

Phase 1
18 Years
Open (Enrolling)
Bladder Cancer

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Trial Information

Image Guided Dose Escalated Adaptive Bladder Radiotherapy



- 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

- 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

- 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

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.

Inclusion Criteria


- Histologically confirmed invasive bladder carcinoma, including the following cellular

- Adenocarcinoma

- Transitional cell carcinoma

- Squamous cell carcinoma

- Clinical stage G1-3, pT2a-4 disease

- Localized disease

- No bone or visceral metastases

- No lymph node metastases

- Has undergone maximal transurethral resection of the bladder tumor and planning to
receive radical radiotherapy


- WHO performance status 0-1

- Hemoglobin > 10 g/dL

- WBC > 3,000/mm^3

- Platelet count > 150,000/mm^3

- Creatinine < 120 ╬╝mol/L

- Bilirubin < 1.5 times upper limit normal (ULN)

- AST < 1.5 times ULN

- Alkaline phosphatase < 1.5 times ULN

- Not pregnant

- No inflammatory bowel disease or other significant small bowel disease

- Physically fit for radical radiotherapy

- No psychological, familial, sociological, or geographical condition potentially
hampering compliance with the study protocol and follow-up schedule

- No other malignancy within the past 2 years except adequately treated basal cell
carcinoma of the skin or adequately treated carcinoma in situ of the cervix uteri

- Prior superficial transitional cell carcinoma of the bladder allowed


- See Disease Characteristics

- No prior pelvic surgery

- No bilateral hip replacements compromising accurate radiotherapy planning

- No prior radiotherapy to the pelvis

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum-tolerated dose

Safety Issue:


Principal Investigator

Robert A. Huddart, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Royal Marsden NHS Foundation Trust



Study ID:




Start Date:

May 2009

Completion Date:

Related Keywords:

  • Bladder Cancer
  • adenocarcinoma of the bladder
  • squamous cell carcinoma of the bladder
  • transitional cell carcinoma of the bladder
  • recurrent bladder cancer
  • stage II bladder cancer
  • stage III bladder cancer
  • stage IV bladder cancer
  • Urinary Bladder Neoplasms