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Heated chemo during second surgery shows promise for ovarian cancer
NCT ID NCT04415944
First seen Jun 27, 2026 · Last updated Aug 11, 2026 · Updated 2 times
Summary
This study looked at whether giving heated chemotherapy directly into the abdomen during a second-look surgery is possible for people with ovarian, fallopian tube, or peritoneal cancer. Ten participants who had already received standard treatment were enrolled. The goal was to see if the procedure could be done safely and how it affected their quality of life.
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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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10 people
The number who actually took part.
- Started
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May 2021
- Finished
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Jan 2026
- Lead sponsor
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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
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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 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.
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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 Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157, United States
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Other studies related to the condition(s) this trial covers.
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