Actively Recruiting
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
Led by Ohio State University Comprehensive Cancer Center · Updated on 2026-02-11
45
Participants Needed
1
Research Sites
237 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase I trial studies the side effects of hyperthermic intraepithelial chemotherapy with cisplatin after surgery or cisplatin before surgery in treating patients with stage III or IV ovarian, fallopian tube or peritoneal cancer receiving chemotherapy before surgery. Hyperthermic intraepithelial chemotherapy involves the infusion of heated cytotoxic chemotherapy that circulates into the abdominal cavity at the time of surgery. Chemotherapy drugs, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving hyperthermic intraepithelial chemotherapy with cisplatin after surgery or cisplatin before surgery may kill more tumor cells compared to usual care.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand English and willing to sign informed consent
- Age over 18 years
- Newly diagnosed stage III or IV epithelial ovarian, fallopian tube, or peritoneal cancer confirmed by biopsy, histology, or cytology with specific diagnostic criteria
- Planned or currently receiving neoadjuvant chemotherapy because optimal primary surgery is not feasible
- Planned interval cytoreductive surgery after 3-4 cycles of neoadjuvant chemotherapy
- Completion of three cycles of carboplatin (AUC 5-6) and paclitaxel (175 mg/m2) every 3 weeks with partial or complete response
- At least 50% decrease in CA-125 level between before chemotherapy and after cycle 3/prior to surgery
- Fit for major surgery with ASA score 1 or 2
- ECOG performance status of 0-2
- Serum creatinine less than 1.4 mg/dL
- Creatinine clearance greater than 60 ml/min
- White blood cell count greater than 3.5 x 10^9 cells/L
- Absolute neutrophil count greater than 1.5 kg/ul
- Platelet count greater than 100,000/ul
- Total bilirubin within 1.5 times normal limits
- AST and ALT less than or equal to 2.5 times upper limit of normal
- Completion of baseline quality of life questionnaires before randomization
You will not qualify if you...
- History of breast cancer or other malignancy within 5 years, except certain skin cancers or cervical carcinoma in situ
- Low grade serous carcinoma or borderline ovarian tumors
- History or current diagnosis of inflammatory bowel disease
- Allergic reactions to cisplatin, carboplatin, or paclitaxel
- Uncontrolled illnesses including active infection, heart failure, unstable angina, or cardiac arrhythmia
- Patients who cannot have optimal or complete cytoreductive surgery at time of surgery will be excluded and replaced
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
T
The Ohio State University Comprehensive Cancer Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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