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COMPLETED
NCT04415944
PHASE2

Trial Evaluating Feasibility and Quality of Life of Second Look Laparoscopy With Hyperthermic Intraperitoneal Chemotherapy

Sponsor: Wake Forest University Health Sciences

View on ClinicalTrials.gov

Summary

The purpose of this research study is to see if it is feasible to receive heated chemotherapy or heated intraperitoneal chemotherapy (HIPEC) inserted directly into the abdomen at the time of a Second Look Reassessment Surgery and to monitor any effects good or bad that this has on participants' health.

Official title: A Phase II Trial Evaluating Feasibility and Quality of Life of Second Look Laparoscopy With HIPEC in Patients With Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2021-05-20

Completion Date

2026-01-23

Last Updated

2026-08-10

Healthy Volunteers

No

Interventions

PROCEDURE

Second look laparoscopy reassessment surgery (SLLRS)

Performed less than 12 weeks after intravenous chemotherapy cycles are completed.

DRUG

HIPEC with Carboplatin

Patient receives HIPEC with CBDCA 800 mg/m2 for 90 minutes. Patients who exhibit the following will not receive the HIPEC procedure: * Extraperitoneal disease noted at the time of the second look procedure * Macroscopic intraperitoneal disease which is not resectable to R1 * Technical problems which prevent continuous, adequate flow to maintain intraperitoneal temperature to 41°C during perfusion * Intraoperative complications such as cardiac or pulmonary instability precluding HIPEC Participation will consist of completing surveys regarding their cancer and allowing researchers to use information from their medical records for research.

OTHER

FACT-O Quality of Life Questionnaire

Participants will be asked to do this three times (pre-study, 3 months and 6 months). Surveys will be given at follow up visits for surgery. They should take about 10-15 minutes to complete.

Locations (1)

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States