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

Last updated: May 15, 2025
Sponsor: Wake Forest University Health Sciences
Overall Status: Active - Recruiting

Phase

2

Condition

Fallopian Tube Cancer

Peritoneal Cancer

Carcinoma

Treatment

FACT-O Quality of Life Questionnaire

Second look laparoscopy reassessment surgery (SLLRS)

HIPEC with Carboplatin

Clinical Study ID

NCT04415944
IRB00066278
WFBCCC 04619
P30CA012197
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients must have histologically I-III epithelial carcinoma of the ovary, fallopiantube or peritoneum or Stage IVA disease in which is there complete resolution ofdisease (pleural effusion) with chemotherapy

  • Patients must have undergone cytoreductive surgery and 3-8 cycles of platinum-basedsystemic chemotherapy prior to the second look surgery. Systemic platinum basedchemotherapy 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 systemicchemotherapy

  • 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 systemicchemotherapy.

  • Age ≥ 18 years.

  • ECOG performance status ≤ 2.

  • Patients must have adequate organ and marrow function as defined below (within 30days 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 upperlimit of normal

  • Adequate contraception and negative pregnancy test if pregnancy possible.

  • Ability to understand and the willingness to sign an IRB-approved informed consentdocument.

Exclusion

Exclusion Criteria:

  • Patients greater than 18 weeks from their last course of systemic platinum basedchemotherapy

  • Patients who have received additional chemotherapy for the ovarian cancer afterprimary therapy as outlined above.

  • Patients may not have received prior abdominal or pelvic radiation.

  • Extensive intra-abdominal adhesive disease noted at the time of initialcytoreductive surgery with PAI of >10 as defined above

  • Intra-abdominal infection associated with initial cytoreductive surgery requiringextended hospitalization or related to systemic chemotherapy requiringhospitalization for therapy

  • History of allergic reactions attributed to compounds of similar chemical orbiologic composition to carboplatin.

  • Uncontrolled intercurrent illness including, but not limited to ongoing or activeinfection, symptomatic congestive heart failure, unstable angina pectoris, cardiacarrhythmia, or psychiatric illness/social situations that would limit compliancewith study requirements.

  • Pregnancy

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

Study Design

Total Participants: 10
Treatment Group(s): 3
Primary Treatment: FACT-O Quality of Life Questionnaire
Phase: 2
Study Start date:
May 20, 2021
Estimated Completion Date:
November 30, 2026

Study 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.

Connect with a study center

  • Wake Forest Baptist Comprehensive Cancer Center

    Winston-Salem, North Carolina 27157
    United States

    Active - Recruiting

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