NCT04415944

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Primary Objective: Determine the feasibility of second look laparoscopy and hyperthermic intraperitoneal chemotherapy with carboplatin. Secondary Objective(s) * To compare the quality of life in participants with ovarian cancer after undergoing second look laparoscopic reassessment surgery with hyperthermic intraperitoneal chemotherapy using carboplatin (CBDCA) versus quality of life in participants treated with cytoreduction surgery and systemic chemotherapy alone. * To describe toxicities in participants with ovarian cancer treated with second look laparoscopy and simultaneous hyperthermic intraperitoneal chemotherapy. OUTLINE: Patients undergo second look laparoscopy. Patients with visible signs of cancer in abdomen also receive HIPEC with carboplatin via intraperitoneal injection (IP) over 90 minutes in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed for up to 6 months.

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

Type	Name	Description
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.

Timeline

• Start date: 2021-05-20
• Primary completion: 2025-09-19
• Completion: 2026-01-23
• First posted: 2020-06-04
• Last updated: 2026-03-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study