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Heated chemo during surgery: a new hope for ovarian cancer?

NCT ID NCT05415709

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Dec 2026

An estimate. End dates often move.

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

18 years and older

Sex

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

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

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.