Adjuvant Radiation for High Risk Bladder Cancer
This phase II trial studies how well modern, conformal radiation therapy after surgery works in treating patients with high-risk bladder cancer. 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.
Squamous Cell Carcinoma of the Bladder
Stage III Bladder Cancer
Stage IV Bladder Cancer
Transitional Cell Carcinoma of the Bladder
Radiation: 3D conformal radiation therapy
Procedure: quality-of-life assessment
Procedure: therapeutic conventional surgery
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Adjuvant 3D-Conformal Radiotherapy in High Risk Bladder Cancer|
- Gastrointestinal (GI) late effects, assessed using Radiation Therapy Oncology Group (RTOG) Late Effects in Normal Tissues (LENT)/Subjective, Objective, Management and Analytic (SOMA) scales [ Time Frame: 3 months to 10 yrs ] [ Designated as safety issue: Yes ]For purposes of this study, "bowel adverse events" are defined as the following: diarrhea, enteritis, fistula, ileus, incontinence, obstruction, perforation, proctitis, and stricture/stenosis (including anastomotic) as graded buy Common Terminology for Adverse Events (CTCAE) version 4.0.
- Acute adverse events greater than grade 2, graded by CTCAE version 4.0 [ Time Frame: Up to 90 days ] [ Designated as safety issue: Yes ]
- Loco-regional failure, considered any failure in the treatment field of the pelvis [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]The cumulative incidence approach will be used to estimate the failure rate for local-regional and distant failures.
- Rate of distant metastases [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]Nodal disease beyond the common iliac will be considered distant failure. The cumulative incidence approach will be used to estimate the failure rate for distant failure.
- Rate of disease-free survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]Any tumor recurrence, development of distant metastases or death is considered a failure. The Kaplan-Meier method will be used to estimate the disease-free survival rate.
- Overall survival rate [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]Death from any cause is considered a failure. The Kaplan-Meier method will be used to estimate the overall survival.
- Quality of life, assessed using FACT-BL [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||July 2013|
|Estimated Primary Completion Date:||July 2017 (Final data collection date for primary outcome measure)|
Experimental: 3D conformal radiation therapy
Within 12 weeks of surgical resection, patients undergo conformal radiation therapy once daily 5 days per week for 28 fractions. Treatment continues in the absence of disease progression or unacceptable toxicity.
Radiation: 3D conformal radiation therapy
Undergo conformal radiation therapy
Other Names:Procedure: quality-of-life assessment
Other Name: quality of life assessmentProcedure: therapeutic conventional surgery
Undergo surgical resection
I. Determine the feasibility of adjuvant radiation in the management of high-risk disease.
I. Prospectively evaluate patterns of failure in high-risk bladder cancer patients after cystectomy and aggressive adjuvant therapy.
II. Define surgical and histopathologic parameters predictive of local and distant outcomes (e.g. grade, lymphovascular space invasion [LVSI], extent of resection/lymph node dissection [LND]).
III. Assess quality of life (QoL) outcomes after this treatment using a standardized questionnaires (Functional Assessment of Cancer Therapy-General [FACT-G], FACT-Bladder Cancer [BL], Expanded Prostate Cancer Index Composite [EPIC] Bowel and Urinary).
Within 12 weeks of surgical resection, patients undergo 3D conformal radiation therapy once daily 5 days per week for 28 fractions. Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 4 weeks, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01954173
|Contact: Joseph W. Shelton, MDfirstname.lastname@example.org|
|United States, Georgia|
|Emory University Hospital||Recruiting|
|Atlanta, Georgia, United States, 30322|
|Contact: Joseph W. Shelton 404-616-6343 email@example.com|
|Principal Investigator: Joseph W. Shelton|
|Principal Investigator:||Joseph W. Shelton, MD||Emory University|