Back to search results

Cisplatin Before or During Surgery for Ovarian, Fallopian Tube, or Peritoneal Cancer

This study is looking at two ways to give cisplatin, a chemotherapy drug, to people with stage III or IV ovarian, fallopian tube, or peritoneal cancer. You would first receive standard chemotherapy (carboplatin and paclitaxel) before surgery. Then, you would be randomly assigned to one of two groups: either receive cisplatin through an IV the day before your surgery, or receive heated cisplatin directly into your abdomen (Hyperthermic Intraperitoneal Chemotherapy or HIPEC) during your surgery. Researchers want to see which method causes fewer side effects within 30 days after treatment. This study aims to find out if giving cisplatin this way can kill more cancer cells than usual care. You can join if you are over 18, speak English, and have newly diagnosed stage III or IV epithelial ovarian, fallopian tube, or peritoneal cancer.

Study design
This is an interventional study with an unclear phase, planning to enroll 45 participants. Participants are randomly assigned to one of two treatment groups.
What's involved
You would receive standard chemotherapy for 3-4 cycles, followed by surgery. You would also provide stool samples and undergo diagnostic imaging throughout the trial.
Compensation
Not stated in the trial record.
Follow-up
After completing study treatment, you will be followed up for up to 30 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05415709

Hyperthermic Intraperitoneal Chemotherapy With Cisplatin During Surgery or Cisplatin Before Surgery for the Treatment of Stage III or IV Ovarian, Fallopian Tube or Peritoneal Cancer

Active, Not Recruiting
EARLY_PHASE1Ages 18+InterventionalTreatment
Ohio State University Comprehensive Cancer Center
~35 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:CarboplatinCisplatinCytoreductive SurgeryHyperthermic Intraperitoneal ChemotherapyPaclitaxelQuality-of-Life Assessment

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of chemotherapy-related adverse events
Measured over 30 days from perioperative treatment

Conditions

Fallopian Tube Endometrioid Adenocarcinoma
Fallopian Tube Mucinous Adenocarcinoma
Fallopian Tube Serous Adenocarcinoma
Ovarian Endometrioid Adenocarcinoma
Ovarian Mucinous Adenocarcinoma
Ovarian Serous Adenocarcinoma
Primary Peritoneal Endometrioid Adenocarcinoma
Primary Peritoneal Serous Adenocarcinoma
Stage III Fallopian Tube Cancer AJCC v8
Stage III Ovarian Cancer AJCC v8
Stage III Primary Peritoneal Cancer AJCC v8
Stage IIIA Fallopian Tube Cancer AJCC v8
Stage IIIA Ovarian Cancer AJCC v8
Stage IIIA Primary Peritoneal Cancer AJCC v8
Stage IIIA1 Fallopian Tube Cancer AJCC v8
Stage IIIA1 Ovarian Cancer AJCC v8
Stage IIIA2 Fallopian Tube Cancer AJCC v8
Stage IIIA2 Ovarian Cancer AJCC v8
Stage IIIB Fallopian Tube Cancer AJCC v8
Stage IIIB Ovarian Cancer AJCC v8
Stage IIIB Primary Peritoneal Cancer AJCC v8
Stage IIIC Fallopian Tube Cancer AJCC v8
Stage IIIC Ovarian Cancer AJCC v8
Stage IIIC Primary Peritoneal Cancer AJCC v8
Stage IV Fallopian Tube Cancer AJCC v8
Stage IV Ovarian Cancer AJCC v8
Stage IV Primary Peritoneal Cancer AJCC v8
Stage IVA Fallopian Tube Cancer AJCC v8
Stage IVA Ovarian Cancer AJCC v8
Stage IVA Primary Peritoneal Cancer AJCC v8
Stage IVB Fallopian Tube Cancer AJCC v8
Stage IVB Ovarian Cancer AJCC v8
Stage IVB Primary Peritoneal Cancer AJCC v8

Explore related trials

Fallopian Tube CarcinomaMalignant Ovarian NeoplasmPrimary Peritoneal CancerCarcinoembryonic AntigenMUC16 wt Allele

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Floor Backes, MD · PRINCIPAL_INVESTIGATOR · Ohio State University Comprehensive Cancer Center

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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

What this trial measures

  • Incidence of chemotherapy-related adverse events30 days from perioperative treatment

    Defined by Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0.