HIPEC After Radical Cystectomy for High Risk Bladder Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03514888|
Recruitment Status : Enrolling by invitation
First Posted : May 2, 2018
Last Update Posted : June 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Invasive Bladder Cancer||Procedure: HIPEC||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||HIPEC with Mitomycin-C|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study for Hyperthermic Intraperitoneal Chemotherapy After Radical Cystectomy With Pelvic Lymph Node Dissection for High Risk Invasive Bladder Cancer|
|Actual Study Start Date :||April 19, 2018|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||April 2020|
Experimental: HIPEC after Radical Cystectomy
After completion of radical cystectomy, HIPEC will be administered using closed abdomen technique for a duration of 60 minutes.
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.
Other Name: Hyperthermic intraperitoneal chemotherapy
- Treatment toxicity [ Time Frame: 90 days ]Treatment toxicity will be analyzed using NCI Common Terminology Criteria for Adverse Events-Version 4.0. Descriptive statistics will be used to determine proportion of grade III/V treatment toxicity. Expected grade III/V toxicity in surgical patients without HIPEC would be 3 out of 10 patients. With the addition of HIPEC, there would be a significant difference (p=0.05) if 6 out of 10 patients experienced a grade III/V toxicity. Therefore, if less than 6 patients experience a grade III/V we would consider this a "negative" finding.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03514888
|United States, New York|
|Weill Cornell Medicine - New York Presbyterian Hospital|
|New York, New York, United States, 10065|
|Principal Investigator:||Douglas S Scherr, MD||Weill Cornell Medicine - New York Presbyterian Hospital|
|Principal Investigator:||Benjamin L Taylor, MD||Weill Cornell Medicine - New York Presbyterian Hospital|