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
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.
OBJECTIVES:
Primary
Secondary
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.
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 →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.
DISEASE CHARACTERISTICS:
Histologically confirmed invasive bladder carcinoma, including the following cellular types:
Clinical stage G1-3, pT2a-4 disease
PATIENT CHARACTERISTICS:
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 CONCURRENT THERAPY:
Maximum-tolerated dose
Progression-free survival
Overall survival
Bladder preservation rates
Acute and late toxicity and safety profile
Quality of life
Tumor boost volumes delineated with and without gold seeds
Dose-volume histogram analysis of PTV2 and PTV3 coverage
Change in diffusion coefficient between pre- and post-radiotherapy dwMRI scans
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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Institute of Cancer Research, United Kingdom