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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2011 by National Cancer Institute (NCI)
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01124682
First received: May 14, 2010
Last updated: August 23, 2013
Last verified: February 2011
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Image Guided Dose Escalated Adaptive Bladder Radiotherapy

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Maximum-tolerated dose [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Bladder preservation rates [ Designated as safety issue: No ]
  • Acute and late toxicity and safety profile [ Designated as safety issue: Yes ]
  • Quality of life [ Designated as safety issue: No ]
  • Tumor boost volumes delineated with and without gold seeds [ Designated as safety issue: No ]
  • Dose-volume histogram analysis of PTV2 and PTV3 coverage [ Designated as safety issue: No ]
  • Change in diffusion coefficient between pre- and post-radiotherapy dwMRI scans [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: May 2009
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior pelvic surgery
  • No bilateral hip replacements compromising accurate radiotherapy planning
  • No prior radiotherapy to the pelvis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01124682

Locations
United Kingdom
Royal Marsden - Surrey Recruiting
Sutton, England, United Kingdom, SM2 5PT
Contact: Contact Person    44-20-8661-3457    robert.huddart@icr.ac.uk   
Sponsors and Collaborators
Institute of Cancer Research, United Kingdom
Investigators
Principal Investigator: Robert A. Huddart, MD Royal Marsden NHS Foundation Trust
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT01124682     History of Changes
Other Study ID Numbers: CDR0000671670, ICR-IDEAL, EU-21035, CCR-3217, MREC-09/H0801/40
Study First Received: May 14, 2010
Last Updated: August 23, 2013
Health Authority: Unspecified

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:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on September 18, 2014