Actively Recruiting
Randomized Phase I Study Assessing Safety and Tolerability of Hyperthermic Intraperitoneal Chemotherapy Compared to Cisplatin Before Surgery in Stage III/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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of two different approaches using cisplatin chemotherapy in patients with stage III or IV ovarian, fallopian tube, or peritoneal cancer who receive chemotherapy before surgery. This phase I trial compares giving cisplatin intravenously the day before surgery versus using heated cisplatin chemotherapy infused into the abdominal cavity during surgery. The study also looks at treatment feasibility, delays, patient quality of life, cancer recurrence, survival, and changes in gut bacteria. Participants receive carboplatin and paclitaxel intravenously every three weeks for 3 to 4 cycles. After these cycles, patients who respond to treatment undergo interval cytoreductive surgery. Then, they are randomly assigned to one of two groups: one group receives intravenous cisplatin the day before surgery, and the other group receives heated cisplatin chemotherapy (HIPEC) during surgery. Throughout the trial, stool samples and diagnostic imaging are collected to monitor treatment effects. During the study, participants complete quality-of-life questionnaires and provide stool samples at various times. Researchers assess chemotherapy-related side effects within 30 days after treatment, monitor treatment feasibility, and follow patients for up to 30 days after treatment completion. Longer-term outcomes like recurrence-free survival and overall survival are tracked for several years, along with changes in the gut microbiome and tumor response. The total duration of participation varies based on treatment and follow-up schedules.
CONDITIONS
Brief 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 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 due to non-feasibility of optimal primary surgery
- Scheduled for interval cytoreductive surgery after 3-4 cycles of neoadjuvant chemotherapy
- Completion of three cycles of carboplatin and paclitaxel chemotherapy with at least partial or complete response
- At least 50% decrease in CA-125 level between pre-cycle 1 and post-cycle 3 or prior to surgery
- Fit for major surgery with ASA score 1 or 2
- ECOG performance status 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
- Platelets greater than 100,000/ul
- Total bilirubin within 1.5 times normal institutional limits
- AST and ALT less than or equal to 2.5 times institutional upper limit of normal
- Baseline quality of life questionnaires completed before randomization
You will not qualify if you...
- History of breast cancer or other malignancy within 5 years except certain skin cancers 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
- Allergic reactions to cisplatin, carboplatin, or paclitaxel
- Uncontrolled illness such as active infection, symptomatic heart failure, unstable angina, or cardiac arrhythmia
- Patients unable to undergo optimal or complete cytoreductive surgery at the time of surgery will be excluded and replaced
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 9 to 12 weeks
Participants receive carboplatin and paclitaxel intravenous chemotherapy every 3 weeks for 3 to 4 cycles unless disease progresses or toxicity occurs.
3 to 4 visits every 3 weeks
Duration - 1 to 2 days
Participants are randomized to receive either cisplatin IV the day prior to interval cytoreductive surgery or hyperthermic intraperitoneal chemotherapy (HIPEC) with cisplatin during surgery.
1 to 2 visits around the time of surgery
Duration - Up to 30 days
Participants are monitored for safety, quality of life, and recurrence outcomes for up to 30 days after completion of surgery and chemotherapy treatment.
1 to 2 visits post treatment
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
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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