3-Dimensional Conformal Radiation Therapy in Treating Patients With Bladder Cancer Who Have Undergone Transurethral Resection of the Bladder
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Bladder Cancer |
Procedure: diagnostic cystoscopy Procedure: diffusion-weighted magnetic resonance imaging Procedure: implanted fiducial-based imaging Procedure: quality-of-life assessment Radiation: 3-dimensional conformal radiation therapy Radiation: image-guided radiation therapy Radiation: selective external radiation therapy |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Image Guided Dose Escalated Adaptive Bladder Radiotherapy |
- Maximum-tolerated dose [ Designated as safety issue: No ]
- Progression-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Bladder preservation rates [ Designated as safety issue: No ]
- Acute and late toxicity and safety profile [ Designated as safety issue: Yes ]
- Quality of life [ Designated as safety issue: No ]
- Tumor boost volumes delineated with and without gold seeds [ Designated as safety issue: No ]
- Dose-volume histogram analysis of PTV2 and PTV3 coverage [ Designated as safety issue: No ]
- Change in diffusion coefficient between pre- and post-radiotherapy dwMRI scans [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | May 2009 |
| Estimated Primary Completion Date: | April 2016 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United Kingdom | |
| Royal Marsden - Surrey | Recruiting |
| Sutton, England, United Kingdom, SM2 5PT | |
| Contact: Contact Person 44-20-8661-3457 robert.huddart@icr.ac.uk | |
| Principal Investigator: | Robert A. Huddart, MD | Royal Marsden NHS Foundation Trust |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT01124682 History of Changes |
| Other Study ID Numbers: | CDR0000671670, ICR-IDEAL, EU-21035, CCR-3217, MREC-09/H0801/40 |
| Study First Received: | May 14, 2010 |
| Last Updated: | February 18, 2011 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
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 |
Additional relevant MeSH terms:
|
Urinary Bladder Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site |
Neoplasms Urinary Bladder Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013