HIPEC After Radical Cystectomy for High Risk Bladder Cancer

NCT03514888 | Completed

• 1 other identifier: 1708018468
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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

Keywords

High-risk bladder cancer; Urothelial cancer; HIPEC; Mitomycin

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

HIPEC after Radical Cystectomy

EXPERIMENTAL

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

Procedure: HIPEC

Interventions

HIPEC 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.

Also known as: Hyperthermic intraperitoneal chemotherapy

HIPEC after Radical Cystectomy

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary urothelial cell carcinoma of the bladder
• Patient's aged 45-85, both genders.
• ECOG performance status \< 1
• Hematology: ANC \> 1.5x109/L; Platelets \> 100x109/L
• 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.
• 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:
• Lymphovascular invasion
• Variant histology in the background of primary urothelial (notably plasmacytoid)
• Clinical T3 or greater
• Clinical N+
• No prior neoadjuvant chemotherapy (NAC) or lack of response to NAC
• Or any of the following perioperative factors for increased risk of recurrence:
• Palpable concern for extravesical disease
• Tumor spillage/bladder entry

You may not qualify if:

• Subjects who have previously undergone intraperitoneal chemotherapy.
• Subjects with tumor histology other than urothelial cell carcinoma.
• Patients on concurrent anti-cancer therapy other than that allowed in the study.
• 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.
• Subjects with renal insufficiency defined as creatinine \> 1.5x the upper limit of normal or a calculated creatinine clearance of \< 50 cc/min.
• Subjects with a condition which may interfere with the subjects' ability to understand the requirements of the study.
• Known HIV, Hepatitis B or Hepatitis C positive.
• 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.
• Any condition that would preclude the ability to deliver appropriate IP therapy.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medicine - New York Presbyterian Hospital

New York, New York, 10065, United States

Location

MeSH Terms

Interventions

Hyperthermic Intraperitoneal Chemotherapy

Intervention Hierarchy (Ancestors)

Chemotherapy, Adjuvant; Combined Modality Therapy; Therapeutics; Drug Therapy; Hyperthermia, Induced

Study Officials

• Douglas S Scherr, MD

  Weill Cornell Medicine - New York Presbyterian Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: HIPEC with Mitomycin-C

Study Record Dates

• First Submitted: April 20, 2018
• First Posted: May 2, 2018
• Study Start: April 19, 2018
• Primary Completion: July 19, 2021
• Study Completion: May 23, 2023
• Last Updated: August 28, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)