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

Launched by WAKE FOREST UNIVERSITY HEALTH SCIENCES · Jun 1, 2020

Keywords

ClinConnect Summary

This clinical trial is looking into a treatment method for women with certain types of ovarian and fallopian tube cancers. Specifically, it’s studying the use of heated chemotherapy, known as hyperthermic intraperitoneal chemotherapy (HIPEC), during a follow-up surgery called "Second Look Reassessment Surgery." The goal is to see if this treatment is safe and if it helps improve the quality of life for patients. The trial is currently recruiting participants who have had successful initial surgeries and chemotherapy for their cancer.

To be eligible for the trial, participants need to be women aged 18 or older who have been diagnosed with specific stages of ovarian or fallopian tube cancer and have shown no signs of cancer after treatment. They must also have had previous surgeries to remove the cancer and completed a certain number of chemotherapy cycles. If you join the trial, you’ll receive the heated chemotherapy during your follow-up surgery, and the researchers will monitor your health to understand the effects of this treatment. It's important to note that men cannot participate in this trial due to the focus on female-specific cancers.

Gender

FEMALE

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.