Adjuvant Radiation for High Risk Bladder Cancer
Conditions
Bladder Cancer - Squamous Cell Carcinoma of the Bladder - Stage III Bladder Cancer - Stage IV Bladder Cancer - Transitional Cell Carcinoma of the Bladder
Conditions: official terms
Carcinoma - Carcinoma, Squamous Cell - Carcinoma, Transitional Cell - Urinary Bladder Neoplasms
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: 3D conformal radiation therapy Type: Radiation
Name: quality-of-life assessment Type: Procedure
Name: therapeutic conventional surgery Type: Procedure
Overall Status
Recruiting
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 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 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 12 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 years, and then annually thereafter.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Pathologic diagnosis of urothelial or squamous cell carcinoma of the bladder

- Patients must have undergone cystectomy (total cystectomy, radical cystectomy +/- pelvic lymph node dissection) with no evidence of macroscopic residual disease

- Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status of 0-2

- Patients treated with simple cystectomy with macroscopically negative margins are eligible for this study

- Clinical T-stage (prior to systemic therapy, if applicable) ≥ T3a and/or positive lymph nodes by transurethral resection of bladder tumor (TURBT)/magnetic resonance imaging (MRI)/computed tomography (CT)/positron emission tomography (PET)-CT or pathologic T-stage ≥ T3a and/or positive lymph nodes

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:

- Unstable angina and/or congestive heart failure requiring hospitalization in the last 3 months

- Transmural myocardial infarction within the last 6 months

- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration

- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration

- Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol; the need to exclude patients with AIDS from this protocol is necessary because the treatment involved in this protocol may be significantly immunosuppressive; protocol-specific requirements may also exclude immunocompromised patients
Location
Emory University Hospital
Atlanta, Georgia, United States
Status: Recruiting
Contact: Joseph W. Shelton - 404-616-6343 - jwshelt@emory.edu
Start Date
July 2013
Sponsors
Emory University
Source
Emory University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page