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

NCT04415944 | Completed Phase 2 DMC FDA Drug

• 3 other identifiers: IRB00066278WFBCCC 04619P30CA012197
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Number of Patients To Successfully Undergo Second Look Laparoscopy and Hyperthermic Intraperitoneal Chemotherapy

  The proportion of feasibility is defined as the number of patients who successfully undergo SLL and HIPEC divided by the number of patients who are eligible and consent to participate. The feasibility proportion and its 95% confidence interval will be estimated.

  Up to 3 months post treatment

Secondary Outcomes (2)

• Quality of Life - Functional Assessment of Cancer Therapy-Ovarian (FACT-O) Questionnaire

  Up to 6 months post-treatment

• Number of Reported Toxicities

  Up to 3 months post treatment

Study Arms (1)

Second Look Laparoscopy and HIPEC with Carboplatin

EXPERIMENTAL

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 Carboplatin; Other: 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.

Second Look Laparoscopy and HIPEC with Carboplatin

FACT-O Quality of Life Questionnaire 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.

Second Look Laparoscopy and HIPEC with Carboplatin

HIPEC with Carboplatin 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.

Second Look Laparoscopy and HIPEC with Carboplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms

Interventions

Hyperthermic Intraperitoneal Chemotherapy; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Intervention Hierarchy (Ancestors)

Chemotherapy, Adjuvant; Combined Modality Therapy; Therapeutics; Drug Therapy; Hyperthermia, Induced; Coordination Complexes; Organic Chemicals

Study Officials

• Laurel Berry, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2020
• First Posted: June 4, 2020
• Study Start: May 20, 2021
• Primary Completion: September 19, 2025
• Study Completion: January 23, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)