Hyperthermic Intraperitoneal Chemotherapy Trial Comparing Quality of Life in Patients With Stage … (NCT03188432) | Clinical Trial Compass
CompletedPhase 2
Hyperthermic Intraperitoneal Chemotherapy Trial Comparing Quality of Life in Patients With Stage IIIC-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
United States50 participantsStarted 2019-01-02
Plain-language summary
This phase II trial studies how well hyperthermic intraperitoneal chemotherapy works in improving quality of life in patients with stage IIIC-IV ovarian, fallopian tube, or primary peritoneal cancer. In hyperthermic intraperitoneal chemotherapy, the chemotherapy is warmed before being used and may help the drugs get into the cancer cells better, minimize the toxicity of the drugs on normal cells, and help to kill any cancer cells left over after surgery.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion Criteria:
* Patients must have histologically or cytologically confirmed non-mucinous, epithelial stage 3 or 4 carcinoma of the ovary, fallopian tube or peritoneum.
* Patients must not have received treatment for another malignancy within 3 years of enrollment (patients who have received hormone therapy within 3 years of enrollment are still eligible).
* Patients must have received at least 3 but not more than 6 cycles of carboplatin-doublet based IV neoadjuvant chemotherapy and achieved at least stable disease (radiographically confirmed) at the conclusion of this therapy.
* Age ≥ 18 years.
* Eastern Cooperative Oncology Group (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 (within 30 days of registration)
* Platelets \>= 75,000/mcL (within 30 days of registration)
* Total bilirubin =\< 1.5 mg/dL (within 30 days of registration)
* Creatinine clearance \>= 50 mg/dL (within 30 days of registration)
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) =\< 3 x institutional upper limit of normal (within 30 days of registration)
* Alkaline phosphatase =\< 3 x institutional upper limit of normal (within 30 days of registration)
* The effects of HIPEC on the developing human fetus are unknown. For this reason, and because carboplat…
What they're measuring
1
Quality of Life (QOL) Assessed Using Functional Assessment of Cancer Therapy-Ovarian Questionnaire (FACT-O)