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A Minimally-invasive Approach to Cytoreduction and HIPEC for Peritoneal Surface Malignancy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02463877
Recruitment Status : Active, not recruiting
First Posted : June 4, 2015
Last Update Posted : July 3, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Kaitlyn J Kelly, University of California, San Diego

Brief Summary:

The purpose of this study is to determine the feasibility of surgical techniques involving minimal entry into the living body approach for tumor reduction and treatment in which highly concentrated anticancer drugs are put directly into the abdomen through a tubes (HIPEC), and to determine if this approach may improve short-term postoperative outcomes, including the development of complications related to surgery within the first 30 days after surgery.

Participation in this study is entirely voluntary. Approximately 30 subjects will take part in this single-center study and all will be enrolled at University of California San Diego.


Condition or disease Intervention/treatment Phase
Cancer Procedure: Minimally-Invasive Procedure Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Minimally-invasive Approach to Cytoreduction and HIPEC for Peritoneal Surface Malignancy
Study Start Date : October 2014
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 5, 2023

Arm Intervention/treatment
Minimally-Invasive Procedure
single-arm study of laparoscopic cytoreduction and HIPEC
Procedure: Minimally-Invasive Procedure
Laparoscopy




Primary Outcome Measures :
  1. Rate of postoperative complications [ Time Frame: within 30 days of surgery ]
    Rate of postoperative complications within 30 days of surgery: this will be expressed as simple ratio with 95% confidence intervals.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Aged > 18 years old
  2. Capable of providing informed consent.
  3. Histologically confirmed peritoneal carcinomatosis from appendiceal, colorectal, ovarian, or primary mesothelioma, with no systemic metastases.
  4. Evidence of low-volume peritoneal disease defined by a PCI < 10 based on cross-sectional imaging / and / or diagnostic laparoscopy findings.
  5. Eastern Cooperative Oncology Group (ECOG) (Zubrod) performance status of 0-2.
  6. Patients who are medically fit for surgery defined as the following:

    • No parenchymal hepatic metastases
    • No evidence of clinical (jaundice), biochemical (abnormally elevated serum bilirubin and/or alkaline phosphatase) or radiological (ultrasound, CT, or MR) biliary obstruction
    • No cross sectional imaging findings indicative of multi-segmental (>1 site) small bowel obstruction, or small bowel loops matted together, or gross disease of the small bowel mesentery characterized by distortion, thickening or loss of mesenteric vascular clarity
    • No clinical or radiological evidence of hematogenous or distant nodal (retroperitoneal, pelvic, mediastinal, peri-portal or peri-aortic) metastasis
    • Absolute neutrophil count (ANC) > 1200/mm3, white blood cell count (WBC) > 4000/mm3 and platelet count > 150,000/mm3
    • An international normalized ratio (INR) ≤ 1.5 (patients who are therapeutically anticoagulated for unrelated medical conditions such as atrial fibrillation and whose antithrombotic treatment can be withheld for operation will be eligible).
    • Adequate hepatic function must be met as evidenced by total serum bilirubin ≤ 1.5 mg/dl (patients with total bilirubin > 1.5 mg/dL eligible only with Gilbert's syndrome);
    • Alkaline phosphatase < 2.5 times the upper limit of normal; and/or
    • Aspartate transaminase (AST) < 1.5 times upper limit of normal (alkaline phosphatase and AST cannot both exceed the upper limit of normal)
    • Serum renal functional parameters, blood urea nitrogen (BUN) and creatinine are within normal limits
    • Satisfactory cardiopulmonary function (no history of severe congestive heart failure or severe pulmonary disease, as indicated by clinically acceptable risks to undergo major abdominal - cytoreductive surgery).
    • No clinical history of acute myocardial infarction within six months of registration.
    • Patients who are status post revascularization procedures with satisfactory cardiac function are eligible.
    • No significant history of a medical problem or co-morbidity that would preclude the patient from undergoing a major abdominal operation such as a history of severe congestive heart failure or active ischemic heart disease.
  7. No concurrent second malignancy requiring systemic therapy.
  8. No psychiatric or addictive disorders or other conditions that would preclude the patient from meeting the study requirements.

Exclusion Criteria:

  1. Peritoneal carcinomatosis index (PCI) > 10
  2. Systemic (extraperitoneal) disease, pregnant, incarcerated.
  3. Pregnant and lactating women. Women of reproductive age must be willing to use contraception during study 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): NCT02463877


Locations
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United States, California
UCSD Moores Cancer Center
La Jolla, California, United States, 92093
Sponsors and Collaborators
University of California, San Diego
Investigators
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Principal Investigator: Kaitlyn Kelly, MD University of California, San Diego

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Responsible Party: Dr. Kaitlyn J Kelly, Assistant Clinical Professor of Surgery, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02463877     History of Changes
Other Study ID Numbers: Minimally-Invasive
First Posted: June 4, 2015    Key Record Dates
Last Update Posted: July 3, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data will be shared with Genelux Corporation
Additional relevant MeSH terms:
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Peritoneal Neoplasms
Neoplasms
Abdominal Neoplasms
Neoplasms by Site
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases