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 range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Quality of Life (QOL) Assessed Using Functional Assessment of Cancer Therapy-Ovarian Questionnaire (FACT-O)