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.
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.
| Overal Status | Start Date | Phase | Study Type |
|---|---|---|---|
| Recruiting | Start Date: July 2013 | N/A | Interventional |
Primary Outcome 1 - Measure: Gastrointestinal (GI) late effects, assessed using Radiation Therapy Oncology Group (RTOG) Late Effects in Normal Tissues (LENT)/Subjective, Objective, Management and Analytic (SOMA) scales
Primary Outcome 1 - Time Frame: 3 months to 10 yrs
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
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Gender: All
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: No
Name: Joseph W Shelton, MD
Role: Principal Investigator
Affiliation: Emory University
Name: Joseph W Shelton, MD
Phone: 404-616-6343
Email: jwshelt@emory.edu
| Facility | Status | Contact |
|---|---|---|
| Emory University Hospital/Winship Cancer Institute Atlanta, Georgia 30322 United States |
Recruiting |
Joseph W Shelton, MD 404-616-6343 jwshelt@emory.edu |
