This phase II trial studies how well 3-dimensional (3D) 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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01954173.
PRIMARY OBJECTIVES:
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 standardized questionnaires (Functional Assessment of Cancer Therapy [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 (QD) 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 2 years, and then annually thereafter.
Lead OrganizationEmory University Hospital/Winship Cancer Institute
Principal InvestigatorJoseph William Shelton