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

Bladder Cancer Clinical Trial

Official title:

Image Guided Dose Escalated Adaptive Bladder Radiotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01124682
• Other study ID #: CDR0000671670
• Secondary ID: ICR-IDEALEU-2103
• Status: Recruiting
• Phase: Phase 1
• First received: May 14, 2010
• Last updated: August 23, 2013
• Start date: May 2009

Study information

• Verified date: February 2011
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• 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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Procedure:
• diagnostic cystoscopy

• diffusion-weighted magnetic resonance imaging

• implanted fiducial-based imaging

• quality-of-life assessment

Radiation:
• 3-dimensional conformal radiation therapy

• image-guided radiation therapy

• selective external radiation therapy

Locations

Country	Name	City	State
United Kingdom	Royal Marsden - Surrey	Sutton	England

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Cancer Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

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