Bladder Cancer Clinical Trial
Official title:
Image Guided Dose Escalated Adaptive Bladder Radiotherapy
Verified date | February 2011 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | Unspecified |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | |
Est. primary completion date | April 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | Royal Marsden - Surrey | Sutton | England |
Lead Sponsor | Collaborator |
---|---|
Institute of Cancer Research, United Kingdom |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum-tolerated dose | No | ||
Secondary | Progression-free survival | No | ||
Secondary | Overall survival | No | ||
Secondary | Bladder preservation rates | No | ||
Secondary | Acute and late toxicity and safety profile | Yes | ||
Secondary | Quality of life | No | ||
Secondary | Tumor boost volumes delineated with and without gold seeds | No | ||
Secondary | Dose-volume histogram analysis of PTV2 and PTV3 coverage | No | ||
Secondary | Change in diffusion coefficient between pre- and post-radiotherapy dwMRI scans | No |
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