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

NCT02463877 | Completed Phase 2 DMC

• 1 other identifier: Minimally-Invasive
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• Rate of postoperative complications

  Rate of postoperative complications within 30 days of surgery: this will be expressed as simple ratio with 95% confidence intervals.

  within 30 days of surgery

Study Arms (1)

Minimally-Invasive Procedure

EXPERIMENTAL

single-arm study of laparoscopic cytoreduction and HIPEC

Procedure: Minimally-Invasive Procedure

Interventions

Minimally-Invasive Procedure PROCEDURE

Laparoscopy

Minimally-Invasive Procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged \> 18 years old
• Capable of providing informed consent.
• Histologically confirmed peritoneal carcinomatosis from appendiceal, colorectal, ovarian, or primary mesothelioma, with no systemic metastases.
• Evidence of low-volume peritoneal disease defined by a PCI \< 10 based on cross-sectional imaging / and / or diagnostic laparoscopy findings.
• Eastern Cooperative Oncology Group (ECOG) (Zubrod) performance status of 0-2.
• 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)

You may not qualify if:

• Peritoneal carcinomatosis index (PCI) \> 10
• Systemic (extraperitoneal) disease, pregnant, incarcerated.
• Pregnant and lactating women. Women of reproductive age must be willing to use contraception during study therapy.

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UCSD Moores Cancer Center

La Jolla, California, 92093, United States

Location

Related Publications (1)

• Cho CY, Veerapong J, Baumgartner JM, Murphy JD, Lowy AM, Kelly KJ. Laparoscopic cytoreductive surgery and hyperthermic intraperitoneal chemotherapy: a prospective clinical trial and comparative analysis. Surg Endosc. 2023 Jul;37(7):5644-5651. doi: 10.1007/s00464-022-09589-w. Epub 2022 Dec 7.

  PMID: 36477643 DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Minimally Invasive Surgical Procedures

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Kaitlyn Kelly, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor of Surgery

Study Record Dates

• First Submitted: April 20, 2015
• First Posted: June 4, 2015
• Study Start: October 1, 2014
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: September 14, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)