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RecruitingEarly Phase 1NCT05415709

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

Randomized Phase I Study Assessing the Safety and Tolerability Hyperthermic Intraperitoneal Chemotherapy (HIPEC) at Completion of Interval Cytoreductive Surgery Compared to Surgery and Chemotherapy Prior to Surgery for Patients With Stage III/IV Ovarian Cancer Undergoing Neoadjuvant Chemotherapy.

Sponsor

Ohio State University Comprehensive Cancer Center

Enrollment

45 participants

Start Date

Jun 13, 2022

Study Type

INTERVENTIONAL

Conditions

Stage III Ovarian Cancer AJCC v8Stage IV Ovarian Cancer AJCC v8Stage IIIA Ovarian Cancer AJCC v8Stage IIIA1 Ovarian Cancer AJCC v8Stage IIIA2 Ovarian Cancer AJCC v8Stage IIIB Ovarian Cancer AJCC v8Stage IIIC Ovarian Cancer AJCC v8Stage III Fallopian Tube Cancer AJCC v8Stage IV Fallopian Tube Cancer AJCC v8Stage III Primary Peritoneal Cancer AJCC v8Stage IIIA Fallopian Tube Cancer AJCC v8Stage IIIA Primary Peritoneal Cancer AJCC v8Stage IIIA1 Fallopian Tube Cancer AJCC v8Stage IIIA2 Fallopian Tube Cancer AJCC v8Stage IIIB Fallopian Tube Cancer AJCC v8Stage IIIB Primary Peritoneal Cancer AJCC v8Stage IIIC Fallopian Tube Cancer AJCC v8Stage IIIC Primary Peritoneal Cancer AJCC v8Stage IV Primary Peritoneal Cancer AJCC v8Stage IVA Fallopian Tube Cancer AJCC v8Stage IVA Ovarian Cancer AJCC v8Stage IVA Primary Peritoneal Cancer AJCC v8Stage IVB Fallopian Tube Cancer AJCC v8Stage IVB Ovarian Cancer AJCC v8Stage IVB Primary Peritoneal Cancer AJCC v8Fallopian Tube Endometrioid AdenocarcinomaFallopian Tube Serous AdenocarcinomaOvarian Endometrioid AdenocarcinomaOvarian Serous AdenocarcinomaPrimary Peritoneal Endometrioid AdenocarcinomaPrimary Peritoneal Serous AdenocarcinomaFallopian Tube Mucinous AdenocarcinomaOvarian Mucinous Adenocarcinoma

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two approaches to treating advanced ovarian, fallopian tube, or peritoneal cancer: giving heated chemotherapy directly into the abdomen during surgery (HIPEC), versus giving standard chemotherapy before surgery. Researchers want to find out which method leads to better outcomes. **You may be eligible if...** - You are 18 or older - You have been newly diagnosed with Stage III or IV ovarian, fallopian tube, or peritoneal cancer - Your diagnosis has been confirmed by biopsy or surgical sample - You are well enough to undergo major surgery (good functional status) - Your organ function (kidneys, liver, blood) is adequate **You may NOT be eligible if...** - You have had prior chemotherapy or surgery for this cancer - You have another active cancer - You have significant heart, lung, or kidney disease - You are pregnant or breastfeeding - You cannot tolerate the medications used in this study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCarboplatin

Given IV

DRUGCisplatin

Given IV

PROCEDURECytoreductive Surgery

Undergo CRS

DRUGHyperthermic Intraperitoneal Chemotherapy

Undergo HIPEC

DRUGPaclitaxel

Given IV

OTHERQuality-of-Life Assessment

Ancillary studies

OTHERQuestionnaire Administration

Ancillary studies

PROCEDUREBiospecimen Collection

Undergo stool sample collection

PROCEDUREDiagnostic Imaging

Undergo diagnostic imaging

Locations(1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

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NCT05415709

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