Clinical trial NCT03514888: HIPEC After Radical Cystectomy for High Risk Bladder Cancer
Official title: A Pilot Study for Hyperthermic Intraperitoneal Chemotherapy After Radical Cystectomy With Pelvic Lymph Node Dissection for High Risk Invasive Bladder Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Invasive Bladder Cancer
Keywords: High-risk bladder cancer
Urothelial cancer
HIPEC
Mitomycin
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2018-05-02
Enrollment: 7
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: HIPEC with Mitomycin-C
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Treatment toxicity
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine - New York Presbyterian Hospital
state: New York
Study officials:
affiliation: Weill Cornell Medicine - New York Presbyterian Hospital
name: Douglas S Scherr, MD
role: PRINCIPAL_INVESTIGATOR
References: