Adjuvant Radiation for High Risk Bladder Cancer

Bladder Cancer Clinical Trial

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

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

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

• NCT number: NCT01954173
• Study type: Interventional
• Source: Emory University
• Status: Terminated
• Phase: N/A
• Start date: July 22, 2013
• Completion date: September 20, 2021