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

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

NCT ID: NCT01124682

Condition: Bladder Cancer

Conditions: Official terms:
Urinary Bladder Neoplasms

Conditions: 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

Study type: Interventional

Study phase: Phase 1

Overall status: Unknown status

Study design:

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: diagnostic cystoscopy

Intervention type: Procedure
Intervention name: diffusion-weighted magnetic resonance imaging

Intervention type: Procedure
Intervention name: implanted fiducial-based imaging

Intervention type: Procedure
Intervention name: quality-of-life assessment

Intervention type: Radiation
Intervention name: 3-dimensional conformal radiation therapy

Intervention type: Radiation
Intervention name: image-guided radiation therapy

Intervention type: Radiation
Intervention name: selective external radiation therapy

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.

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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Royal Marsden - Surrey

Address:
City: Sutton
Zip: SM2 5PT
Country: United Kingdom

Status: Recruiting

Contact:
Last name: Contact Person

Phone: 44-20-8661-3457
Email: robert.huddart@icr.ac.uk

Start date: May 2009

Lead sponsor:
Agency: Institute of Cancer Research, United Kingdom
Agency class: Other

Source: National Cancer Institute (NCI)

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT01124682