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.
PRIMARY OBJECTIVE: I. Determine the feasibility of adjuvant radiation in the management of high-risk disease. SECONDARY OBJECTIVES: 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). OUTLINE: Within 24 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 3-5 years, and then annually thereafter.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
Undergo conformal radiation therapy
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States
Gastrointestinal (GI) late effects, assessed using Radiation Therapy Oncology Group (RTOG) Late Effects in Normal Tissues (LENT)/Subjective, Objective, Management and Analytic (SOMA) scales
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.
Time frame: 3 months to 10 yrs
Acute adverse events greater than grade 2, graded by CTCAE version 4.0
Time frame: Up to 90 days
Loco-regional failure, considered any failure in the treatment field of the pelvis
The cumulative incidence approach will be used to estimate the failure rate for local-regional and distant failures.
Time frame: Up to 5 years
Rate of distant metastases
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.
Time frame: Up to 5 years
Rate of disease-free survival
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.
Time frame: Up to 5 years
Overall survival rate
Death from any cause is considered a failure. The Kaplan-Meier method will be used to estimate the overall survival.
Time frame: Up to 5 years
Quality of life, assessed using FACT-BL
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Time frame: Up to 5 years