Adjuvant Radiation for High Risk Bladder Cancer
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 Study Completion Date:||July 2018|
|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|
|Contact: Giesla Rodgersemail@example.com|
|United States, Georgia|
|Emory University Hospital||Recruiting|
|Atlanta, Georgia, United States, 30322|
|Contact: Joseph W. Shelton 404-616-6343 firstname.lastname@example.org|
|Principal Investigator: Joseph W. Shelton|
|Principal Investigator:||Joseph W. Shelton, MD||Emory University|