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NCT04415944CompletedPhase 2

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

Source: ClinicalTrials.gov · Last updated 10 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
10 (actual)
First submitted
1 Jun 2020
Start date
20 May 2021
Primary completion date
19 Sept 2025
Lead sponsor
Wake Forest University Health Sciences
NCT number
NCT04415944

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 10
  • From 20 May 2021 to the primary completion date, 19 Sept 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Wake Forest Baptist Comprehensive Cancer Center
Coordinator of this site? Confirm its status
Winston-SalemUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.