NCT01954173

Adjuvant Radiation for High Risk Bladder Cancer

Phase II Study of Adjuvant 3D-Conformal Radiotherapy in High Risk Bladder Cancer

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Bladder Cancer
• Squamous Cell Carcinoma of the Bladder
• Stage III Bladder Cancer
• Stage IV Bladder Cancer
• Transitional Cell Carcinoma of the Bladder

Interventions

Type	Name	Description
RADIATION	3D conformal radiation therapy	Undergo conformal radiation therapy

Timeline

• Start date: 2013-07-22
• Primary completion: 2021-09-20
• Completion: 2021-09-20
• First posted: 2013-10-01
• Last updated: 2022-03-02

Locations

1 site across 1 country: United States