HIPEC After Radical Cystectomy for High Risk Bladder Cancer

NCT ID: NCT03514888

Last Updated: 2023-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-19
• Study Completion Date: 2023-05-23

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HIPEC after Radical Cystectomy

After completion of radical cystectomy, HIPEC will be administered using closed abdomen technique for a duration of 60 minutes.

Group Type: EXPERIMENTAL

HIPEC

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

Hyperthermic intraperitoneal chemotherapy

Eligibility Criteria

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Douglas S Scherr, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Cornell Medicine - New York Presbyterian Hospital

Locations

Weill Cornell Medicine - New York Presbyterian Hospital

New York, New York, United States

Countries

United States

Other Identifiers

1708018468

Identifier Type: -

Identifier Source: org_study_id