Bladder Cancer Clinical Trial
Official title:
Phase II Study of Adjuvant 3D-Conformal Radiotherapy in High Risk Bladder Cancer
Verified date | February 2022 |
Source | Emory University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 19 |
Est. completion date | September 20, 2021 |
Est. primary completion date | September 20, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Emory University Hospital/Winship Cancer Institute | Atlanta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Emory University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Gastrointestinal (GI) late effects, assessed using Radiation Therapy Oncology Group (RTOG) Late Effects in Normal Tissues (LENT)/Subjective, Objective, Management and Analytic (SOMA) scales | For purposes of this study, "bowel adverse events" are defined as the following: diarrhea, enteritis, fistula, ileus, incontinence, obstruction, perforation, proctitis, and stricture/stenosis (including anastomotic) as graded buy Common Terminology for Adverse Events (CTCAE) version 4.0. | 3 months to 10 yrs | |
Secondary | Acute adverse events greater than grade 2, graded by CTCAE version 4.0 | Up to 90 days | ||
Secondary | Loco-regional failure, considered any failure in the treatment field of the pelvis | The cumulative incidence approach will be used to estimate the failure rate for local-regional and distant failures. | Up to 5 years | |
Secondary | Rate of distant metastases | Nodal disease beyond the common iliac will be considered distant failure. The cumulative incidence approach will be used to estimate the failure rate for distant failure. | Up to 5 years | |
Secondary | Rate of disease-free survival | Any tumor recurrence, development of distant metastases or death is considered a failure. The Kaplan-Meier method will be used to estimate the disease-free survival rate. | Up to 5 years | |
Secondary | Overall survival rate | Death from any cause is considered a failure. The Kaplan-Meier method will be used to estimate the overall survival. | Up to 5 years | |
Secondary | Quality of life, assessed using FACT-BL | Up to 5 years |
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