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Status unknownNCT01124682Updated Aug 26, 2013

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

A Phase 1 interventional study of diagnostic cystoscopy and diffusion-weighted magnetic resonance imaging in Bladder Cancer, sponsored by Institute of Cancer Research, United Kingdom. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-08-26.

Sponsored by Institute of Cancer Research, United Kingdom · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2011), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
60
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Bladder Cancer

Keywords

  • 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
03

In context

Urinary Bladder Neoplasms

1,616 studies on the registry are indexed under Urinary Bladder Neoplasms; 421 are open to participants now.

This study's planned enrollment of 60 is close to the median of 60 across 1,163 interventional studies indexed under Urinary Bladder Neoplasms.

Browse Urinary Bladder Neoplasms studies →

Lead sponsor

Institute of Cancer Research, United Kingdom is the lead sponsor of 111 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Masking
None (open label)
Enrollment
60 participants (estimated)

Interventions

  • Procedurediagnostic cystoscopy
  • Procedurediffusion-weighted magnetic resonance imaging
  • Procedureimplanted fiducial-based imaging
  • Procedurequality-of-life assessment
  • Radiation3-dimensional conformal radiation therapy
  • Radiationimage-guided radiation therapy
  • Radiationselective external radiation therapy
06

What researchers measure

Primary outcomes

  1. Maximum-tolerated dose

Secondary outcomes

  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

07

Study locations

1 of 1 sites recruiting
  • Royal Marsden - Surrey
    Sutton, England SM2 5PT, United Kingdom
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 26, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01124682
Lead sponsor
Institute of Cancer Research, United Kingdom
First posted
May 17, 2010
Start date
May 2009
Primary completion
Apr 2016 (estimated)
Last update
Aug 26, 2013

Study contacts

Robert A. Huddart, MD
principal investigator · Royal Marsden NHS Foundation Trust
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2011. You cannot join it, but the record below documents what was studied.

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