Spots Global Cancer Trial Database for Adjuvant Radiation for High Risk Bladder Cancer

Study Description

Brief 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

Useful links and downloads for this trial