Heated chemo during surgery: a new hope for ovarian cancer?
NCT ID NCT05415709
First seen Jun 26, 2026 · Last updated Aug 18, 2026 · Updated 3 times
Summary
This early-phase trial is testing whether giving heated chemotherapy directly into the abdomen during surgery is safe for people with advanced ovarian, fallopian tube, or peritoneal cancer. Participants will receive standard chemotherapy before surgery, and then either heated chemo during surgery or extra chemo the day before. The study aims to see which approach has fewer side effects and is more practical.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Cisplatin (heated chemotherapy given into the abdomen during surgery)
- What this could lead to
- If this approach is safe and feasible, it could lead to a larger trial testing whether heated chemotherapy during surgery helps people with advanced ovarian cancer live longer.
- What could go wrong
- This is a very early (Phase 1) trial with only 45 people. It is designed to check safety, not effectiveness. Heated chemotherapy can cause serious side effects like infection, organ damage, or blood clots.
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
-
Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
-
35 people
The number who actually took part.
- Started
-
Jun 2022
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- 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
-
18 years and older
- Sex
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Anyone
- 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: * Ability to understand (English-speaking), and willingness to sign a written, informed consent * Age \> 18 years old * Newly diagnosed stage III or IV epithelial (serous, mucinous, or endometrioid) ovarian, fallopian tube or peritoneal cancer diagnosed by: * Biopsy/histology (either by interventional radiology or laparoscopy) OR * Cytology; If diagnosis is based on cytology the following criteria must be met: * Immunohistochemistry on the block from cytology to demonstrate Mullerian origin * Presence of pelvic mass AND CA 125 \> 200kU/I AND CA125/CEA ratio \> 25 at initial diagnosis * Omental cake or other metastases larger than 2 cm in the upper abdomen and/or regional lymph node metastasis irrespective of size (diagnosed by computed tomography \[CT\]/magnetic resonance imaging \[MRI\], ultrasound, or laparoscopy) * Patient planned for or currently receiving neoadjuvant chemotherapy due to the fact that optimal primary CRS was determined not to be feasible by the primary surgeon * Patient must be planned or scheduled to undergo interval cytoreductive surgery after cycle 3-4 of neoadjuvant surgery * Completion of three cycles of neoadjuvant chemotherapy (NACT) with standard therapy (carboplatin \[area under the curve (AUC) 5-6\] day \[D\]1 + paclitaxel \[175 mg/m\^2\] D1 every 3 weeks) * Following 3-4 cycles of NACT partial or complete response * Following 3-4 cycles of NACT at least 50% decrease in CA-125 level between pre-cycle 1 and post-cycle 3/prior to surgery * Fit for major surgery, American Society of Anesthesiologists (ASA )1 or ASA 2 * Eastern Cooperative Oncology Group (ECOG) performance-status score of 0-2 * Serum creatinine \< 1.4 mg/dL * Creatinine clearance \> 60 ml/min (Cockcroft-Gault formula) * White blood cell count \> 3.5 x 10\^9 cells/L * Absolute neutrophil count \> 1.5 kg/ul * Platelets \> 100,000/ul * Total bilirubin within 1.5 x normal institutional limits * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x institutional upper limit of normal * For quality of life assessment, baseline questionnaires should be filled in before randomization Exclusion Criteria: * History of breast cancer or previous malignancy within 5 years prior to inclusion, with the exception of radically excised basal cell or squamous cell skin cancer or carcinoma in situ of the cervix * Low grade serious carcinoma of the ovary or borderline ovarian tumors * History or current diagnosis of inflammatory bowel disease * History of allergic reactions to compounds of similar chemical or biologic composition to cisplatin, carboplatin, and paclitaxel * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia * Patients in whom an optimal or complete cytoreduction cannot be performed will be excluded at the time of surgery and be replaced
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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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Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
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Other studies related to the condition(s) this trial covers.
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