Trial Evaluating Feasibility and Quality of Life of Second Look Laparoscopy With Hyperthermic Int… (NCT04415944) | Clinical Trial Compass
CompletedPhase 2
Trial Evaluating Feasibility and Quality of Life of Second Look Laparoscopy With Hyperthermic Intraperitoneal Chemotherapy
United States10 participantsStarted 2021-05-20
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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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 c…
What they're measuring
1
Number of Patients To Successfully Undergo Second Look Laparoscopy and Hyperthermic Intraperitoneal Chemotherapy