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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
National Cancer Institute (NCI)

Brief 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.

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

Detailed Description:



  • 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Image Guided Dose Escalated Adaptive Bladder Radiotherapy
Study Start Date : May 2009
Estimated Primary Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Primary Outcome Measures :
  1. Maximum-tolerated dose

Secondary Outcome Measures :
  1. Progression-free survival
  2. Overall survival
  3. Bladder preservation rates
  4. Acute and late toxicity and safety profile
  5. Quality of life
  6. Tumor boost volumes delineated with and without gold seeds
  7. Dose-volume histogram analysis of PTV2 and PTV3 coverage
  8. Change in diffusion coefficient between pre- and post-radiotherapy dwMRI scans

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed invasive bladder carcinoma, including the following cellular types:

    • 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 μmol/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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01124682

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United Kingdom
Royal Marsden - Surrey Recruiting
Sutton, England, United Kingdom, SM2 5PT
Contact: Contact Person    44-20-8661-3457   
Sponsors and Collaborators
Institute of Cancer Research, United Kingdom
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Principal Investigator: Robert A. Huddart, MD Royal Marsden NHS Foundation Trust

Layout table for additonal information Identifier: NCT01124682     History of Changes
Other Study ID Numbers: CDR0000671670
First Posted: May 17, 2010    Key Record Dates
Last Update Posted: August 26, 2013
Last Verified: February 2011

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases