HIPEC After Radical Cystectomy for High Risk Bladder Cancer

Invasive Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03514888
• Other study ID #: 1708018468
• Status: Completed
• Phase: N/A
• Start date: April 19, 2018
• Est. completion date: May 23, 2023

Study information

• Verified date: August 2023
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: May 23, 2023
• Est. primary completion date: July 19, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Invasive Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Weill Cornell Medicine - New York Presbyterian Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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