HIPEC After Radical Cystectomy for High Risk Bladder Cancer
NCT03514888 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7
Last updated 2023-08-28
Summary
This is a non-randomized, non-blinded, pilot study administering hyperthermic intraperitoneal chemotherapy with Mitomycin-C in 10 men and women with muscle-invasive urothelial carcinoma of the bladder undergoing radical cystectomy with pelvic lymph node dissection who have risk factors for tumor recurrence.
Conditions
- Invasive Bladder Cancer
Interventions
- PROCEDURE
-
HIPEC
40mg of Mitomycin-C dissolved in 100ml normal saline will be added into the perfusate and instilled into the patient for a total of 60 minutes. After 60 minutes, the abdomen will be irrigated with 3 liters of normal saline.
Sponsors & Collaborators
-
Weill Medical College of Cornell University
lead OTHER
Principal Investigators
-
Douglas S Scherr, MD · Weill Cornell Medicine - New York Presbyterian Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 45 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2018-04-19
- Primary Completion
- 2021-07-19
- Completion
- 2023-05-23
Countries
- United States
Study Locations
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