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HIPEC After Radical Cystectomy for High Risk Bladder Cancer

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ClinicalTrials.gov Identifier: NCT03514888
Recruitment Status : Enrolling by invitation
First Posted : May 2, 2018
Last Update Posted : June 13, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Invasive Bladder Cancer Procedure: HIPEC Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Intervention Model Description: HIPEC with Mitomycin-C
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study for Hyperthermic Intraperitoneal Chemotherapy After Radical Cystectomy With Pelvic Lymph Node Dissection for High Risk Invasive Bladder Cancer
Actual Study Start Date : April 19, 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HIPEC after Radical Cystectomy
After completion of radical cystectomy, HIPEC will be administered using closed abdomen technique for a duration of 60 minutes.
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.
Other Name: Hyperthermic intraperitoneal chemotherapy




Primary Outcome Measures :
  1. Treatment toxicity [ Time Frame: 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.



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Ages Eligible for Study:   45 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03514888


Locations
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United States, New York
Weill Cornell Medicine - New York Presbyterian Hospital
New York, New York, United States, 10065
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
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Principal Investigator: Douglas S Scherr, MD Weill Cornell Medicine - New York Presbyterian Hospital
Principal Investigator: Benjamin L Taylor, MD Weill Cornell Medicine - New York Presbyterian Hospital

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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT03514888     History of Changes
Other Study ID Numbers: 1708018468
First Posted: May 2, 2018    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Weill Medical College of Cornell University:
High-risk bladder cancer
Urothelial cancer
HIPEC
Mitomycin
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Mitomycins
Mitomycin
Antibiotics, Antineoplastic
Antineoplastic Agents
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors