Heated chemo during surgery may ease life for advanced ovarian cancer patients
NCT ID NCT03188432
First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 1 time
Summary
This study tested whether giving heated chemotherapy directly into the abdomen during surgery can improve quality of life for people with advanced ovarian, fallopian tube, or peritoneal cancer. Fifty participants received the treatment after standard chemotherapy. Researchers measured quality of life and abdominal discomfort using questionnaires. The goal was to see if this approach helps patients feel better after treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Carboplatin (heated chemotherapy)
- What this could lead to
- If successful, this approach could improve quality of life for people with advanced ovarian cancer by reducing side effects and better targeting remaining cancer cells after surgery.
- What could go wrong
- This is a small, early-phase study with only 50 participants and no comparison group, so results may not apply broadly. Heated chemotherapy also carries risks like infection or organ damage.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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50 people
The number who actually took part.
- Started
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Jan 2019
- Finished
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Feb 2024
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 carboplatin doublet therapy consists of pregnancy category D agents, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. * Ability to understand and the willingness to sign an institutional review board (IRB)-approved informed consent document. Exclusion Criteria: * Patients may not be receiving any other investigational agents. * Patients with extra-abdominal metastatic disease. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to carboplatin doublet agents. * 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. * Pregnant women are excluded from this study because carboplatin doublet therapy consists of pregnancy category D agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with carboplatin doublet therapy, breastfeeding should be discontinued. * Men are excluded from participating due to the site specific nature of the disease being studied.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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