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

NCT ID: NCT01124682

Last Updated: 2013-08-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31

Brief 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.

Conditions

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

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

diagnostic cystoscopy

Intervention Type: PROCEDURE

diffusion-weighted magnetic resonance imaging

Intervention Type: PROCEDURE

implanted fiducial-based imaging

Intervention Type: PROCEDURE

quality-of-life assessment

Intervention Type: PROCEDURE

3-dimensional conformal radiation therapy

Intervention Type: RADIATION

image-guided radiation therapy

Intervention Type: RADIATION

selective external radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Cancer Research, United Kingdom

OTHER

Sponsor Role: lead

Principal Investigators

Robert A. Huddart, MD

Role: PRINCIPAL_INVESTIGATOR

Royal Marsden NHS Foundation Trust

Locations

Royal Marsden - Surrey

Sutton, England, United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Facility Contacts

Contact Person

Role: primary

Other Identifiers

ICR-IDEAL

Identifier Type: -

Identifier Source: secondary_id

EU-21035

Identifier Type: -

Identifier Source: secondary_id

CCR-3217

Identifier Type: -

Identifier Source: secondary_id

MREC-09/H0801/40

Identifier Type: -

Identifier Source: secondary_id

CDR0000671670

Identifier Type: -

Identifier Source: org_study_id