CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 10 enrolled / 10 target
Drug / intervention
HIPEC with Carboplatin +2 moredrug
Likely dose
HIPEC with Carboplatin 800 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04415944
NCT04415944Phase 2CompletedUpdate Overdue (0.2/mo)Completion was 9mo ago

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

Wake Forest University Health Sciences·interventional·Posted Jun 4, 2020·Updated Jun 22, 2026

In Brief

A Phase 2 clinical trial evaluating Second look laparoscopy reassessment surgery (SLLRS), HIPEC with Carboplatin, and 1 other intervention for Ovarian Epithelial Cancer Stage I and 6 related conditions. Completed, enrolled 10 participants across 1 site.

Signals

Enrollment appears stalled

Detailed 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.

Study Details

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedJun 4, 2020
Enrollment StartMay 20, 2021
Primary CompletionSep 19, 2025
Study CompletionJan 23, 2026
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 6.1 years ago

Arms & Interventions

Second Look Laparoscopy and HIPEC with Carboplatinexperimental

Laparoscopic assessment of disease status of the peritoneal cavity with lysis of adhesions as necessary noting either no gross residual disease or minimal residual disease prior to or after resection. This is performed prior to establishment of a peritoneal perfusion circuit and hyperthermic intraperitoneal chemotherapy.

Procedure: Second look laparoscopy reassessment surgery (SLLRS)Drug: HIPEC with CarboplatinOther: FACT-O Quality of Life Questionnaire

Interventions

Second look laparoscopy reassessment surgery (SLLRS)procedure

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

HIPEC with Carboplatindrug

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.

FACT-O Quality of Life Questionnaireother

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.