HIPEC After Radical Cystectomy for High Risk Bladder Cancer

Not Applicable

Completed

• Conditions: Invasive Bladder Cancer
• Interventions: Procedure: HIPEC

• Registration Number: NCT03514888
• Lead Sponsor: Weill Medical College of Cornell University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-04-19
• Study First Submitted: 2018-04-20
• Study First Submitted QC: 2018-04-20
• Study First Posted: 2018-05-02
• Primary Completion: 2021-07-19
• Study Completion: 2023-05-23
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-24
• Last Update Posted: 2023-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HIPEC after Radical Cystectomy	HIPEC	After completion of radical cystectomy, HIPEC will be administered using closed abdomen technique for a duration of 60 minutes.

Primary Outcome Measures

Name	Time	Method
Treatment toxicity	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.

Trial Locations

Locations (1)

Weill Cornell Medicine - New York Presbyterian Hospital; 🇺🇸 New York, New York, United States