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

NCT ID: NCT04415944

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-20
• Study Completion Date: 2026-01-31

Brief 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 if life in patients with ovarian cancer after undergoing second look laparoscopic reassessment surgery with hyperthermic intraperitoneal chemotherapy using carboplatin (CBDCA) versus quality of life in patients treated with cytoreduction surgery and systemic chemotherapy alone.
• To describe toxicities in patients 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Second Look Laparoscopy and HIPEC with Carboplatin

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.

Group Type: EXPERIMENTAL

Second look laparoscopy reassessment surgery (SLLRS)

Intervention Type: PROCEDURE

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

HIPEC with Carboplatin

Intervention Type: DRUG

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 Questionnaire

Intervention Type: OTHER

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.

Interventions

Second look laparoscopy reassessment surgery (SLLRS)

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

Intervention Type: PROCEDURE

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.

Intervention Type: DRUG

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients must have histologically I-III epithelial carcinoma of the ovary, fallopian tube or peritoneum or Stage IVA disease in which is there complete resolution of disease (pleural effusion) with chemotherapy
• Patients must have undergone cytoreductive surgery and 3-8 cycles of platinum-based systemic chemotherapy prior to the second look surgery. Systemic platinum based chemotherapy must be completed less than 18 weeks prior to second look surgery.
• Cytoreductive surgery must result in an R-0, R-1 resection prior to systemic chemotherapy
• The intraoperative peritoneal adhesion index should be < 10.
• Patients must be without clinical evidence of disease including a negative exam, imaging (CT or PET/CT) and normal tumor markers (CA125) after completion of systemic chemotherapy.
• Age ≥ 18 years.
• ECOG performance status ≤ 2.
• Patients must have adequate organ and marrow function as defined below (within 30 days of registration): absolute neutrophil count >1,500/mcL; platelets >100,000/mcL; total bilirubin ≤ 1.5 mg/dL; creatinine clearance ≥ 50 mg/dL; AST(SGOT)/ALT(SGPT) ≤ 3X; institutional upper limit of normal; alkaline phosphatase 3X institutional upper limit of normal
• Adequate contraception and negative pregnancy test if pregnancy possible.
• Ability to understand and the willingness to sign an IRB-approved informed consent document.

Exclusion Criteria

• Patients greater than 18 weeks from their last course of systemic platinum based chemotherapy
• Patients who have received additional chemotherapy for the ovarian cancer after primary therapy as outlined above.
• Patients may not have received prior abdominal or pelvic radiation.
• Extensive intra-abdominal adhesive disease noted at the time of initial cytoreductive surgery with PAI of >10 as defined above
• Intra-abdominal infection associated with initial cytoreductive surgery requiring extended hospitalization or related to systemic chemotherapy requiring hospitalization for therapy
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to carboplatin.
• Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnancy

Men are excluded from participation due to the site-specific nature of the disease being studied.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laurel Berry, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

WFBCCC 04619

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA012197

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00066278

Identifier Type: -

Identifier Source: org_study_id