RecruitingPhase 2NCT07229040

A Double-blind Non Inferiority Clinical Trial to Compare the Nephroprotection of Cilastatn Versus Thiosulfate in Patients Undergoing Debulking Surgery With Intraoperative Hyperthermic Intraperitoneal Chemotherapy With Cisplatin.


Sponsor

Hospital General Universitario Gregorio Marañon

Enrollment

90 participants

Start Date

Feb 21, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

To compare cilastatin vs thiosulfatein renal protection in patients undergoing debulking surgery with intraoperative hyperthermic intraperitoneal chemotherapy with cisplatin


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study compares two kidney-protecting drugs — cilastatin versus thiosulfate — in women with ovarian cancer who are receiving a specialized treatment called HIPEC (hyperthermic intraperitoneal chemotherapy with cisplatin) during surgery. The goal is to find out which drug better protects the kidneys from cisplatin damage. **You may be eligible if...** - You are a woman between 18 and 75 years old - You have ovarian cancer confined to the abdomen and are eligible for cytoreductive surgery with HIPEC - Your general health is adequate for major surgery (normal or near-normal blood counts and organ function) - A multidisciplinary team has reviewed your case and determined HIPEC is appropriate **You may NOT be eligible if...** - You have cancer spread outside the abdomen (e.g., to the lungs or bones) - You are not medically fit for major surgery - Your general health score is poor (ECOG > 2) - You do not consent to participate 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

DRUGcilastatine

cilastatine 1.5 g

DRUGtiosulfate

tiosulfate


Locations(1)

Hodpsital General Universitario Gregorio Marañón

Madrid, Madrid, Spain

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NCT07229040


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