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

NCT04415944 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-03-19

No results posted yet for this study

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.

Conditions

  • Ovarian Epithelial Cancer Stage I
  • Ovarian Epithelial Cancer Stage II
  • Ovarian Epithelial Cancer Stage III
  • Stage I Fallopian Tube Cancer
  • Stage II Fallopian Tube Cancer
  • Stage III Fallopian Tube Cancer
  • Peritoneal Carcinoma

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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Laurel Berry, MD · Wake Forest University Health Sciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-20
Primary Completion
2025-09-19
Completion
2026-01-23
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04415944 on ClinicalTrials.gov