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About
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.
Full 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.
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Inclusion criteria
Exclusion criteria
Patients with metastatic disease outside of the pelvis
Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years
Prior radiation therapy to the pelvis
Patients with active inflammatory bowel disease
Severe acute co-morbidity, defined as follows:
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19 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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