HIPEC After Radical Cystectomy for High Risk Bladder Cancer

A Pilot Study for Hyperthermic Intraperitoneal Chemotherapy After Radical Cystectomy With Pelvic Lymph Node Dissection for High Risk Invasive Bladder Cancer

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.

Study Overview

• Status: Completed
• Conditions: Invasive Bladder Cancer
• Intervention / Treatment: Procedure: HIPEC

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Weill Cornell Medicine - New York Presbyterian Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Primary urothelial cell carcinoma of the bladder
2. Patient's aged 45-85, both genders.
3. ECOG performance status < 1
4. Hematology: ANC > 1.5x109/L; Platelets > 100x109/L
5. Women with child bearing potential who are negative for pregnancy test (urine or blood) and who agree to use effective contraceptive method. Reliable contraception should be used from trial screening and must be continued throughout the study. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant.

6. Signed and dated written informed consent to participate in this clinical trial must be obtained prior to any study procedure.

   Either any of the following preoperative factors for increased risk of recurrence:

7. Lymphovascular invasion
8. Variant histology in the background of primary urothelial (notably plasmacytoid)
9. Clinical T3 or greater
10. Clinical N+

11. No prior neoadjuvant chemotherapy (NAC) or lack of response to NAC

    Or any of the following perioperative factors for increased risk of recurrence:

12. Palpable concern for extravesical disease
13. Tumor spillage/bladder entry
14. Suspicious nodes or positive intraoperative frozen sections

Exclusion Criteria:

1. Subjects who have previously undergone intraperitoneal chemotherapy.
2. Subjects with tumor histology other than urothelial cell carcinoma.
3. Patients on concurrent anti-cancer therapy other than that allowed in the study.
4. Other prior malignancies, except for cured non-melanoma skin cancer or curatively treated in situ carcinoma of the cervix or adequately treated malignancies for which there has been no evidence of activity for more than 3 years.
5. Subjects with renal insufficiency defined as creatinine > 1.5x the upper limit of normal or a calculated creatinine clearance of < 50 cc/min.
6. Subjects with a condition which may interfere with the subjects' ability to understand the requirements of the study.
7. Known HIV, Hepatitis B or Hepatitis C positive.
8. Subjects with uncontrolled concurrent illness including, but not limited to, ongoing or severe infection requiring antibiotics, symptomatic congestive heart failure, unstable angina pectoris, acute gastrointestinal bleeding, psychiatric illness or other condition which in the opinion of the investigator, places the patient at an unacceptable risk for participation in the study.
9. Any condition that would preclude the ability to deliver appropriate IP therapy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HIPEC after Radical Cystectomy; After completion of radical cystectomy, HIPEC will be administered using closed abdomen technique for a duration of 60 minutes.	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.; Other Names: Hyperthermic intraperitoneal chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment toxicity	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.	90 days

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Investigators: Principal Investigator: Douglas S Scherr, MD, Weill Cornell Medicine - New York Presbyterian Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2018
• Primary Completion (Actual): July 19, 2021
• Study Completion (Actual): May 23, 2023

Study Registration Dates

• First Submitted: April 20, 2018
• First Submitted That Met QC Criteria: April 20, 2018
• First Posted (Actual): May 2, 2018

Study Record Updates

• Last Update Posted (Actual): August 28, 2023
• Last Update Submitted That Met QC Criteria: August 24, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: HIPEC; Urothelial cancer; Mitomycin; High-risk bladder cancer
• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: 1708018468

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No