Actively Recruiting
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.
Led by Hospital General Universitario Gregorio Marañon · Updated on 2025-11-14
90
Participants Needed
1
Research Sites
191 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To compare cilastatin vs thiosulfatein renal protection in patients undergoing debulking surgery with intraoperative hyperthermic intraperitoneal chemotherapy with cisplatin
CONDITIONS
Official Title
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult female patients aged 18 to 75 years
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 2 or less
- Eligible for major surgery with creatinine, bilirubin, and blood counts within or close to normal ranges (hemoglobin >10 g/dL, leukocytes >3,000/mL, neutrophils >1,000/mL, platelets >100,000/mL)
- Evaluated and cleared for surgery by Anesthesiology Department
- Disease confined to the abdomen; limited metastases to spleen or liver may be considered
- Regional or distant intra-abdominal lymphatic spread allowed if complete resection is feasible
- FIGO stage IVA epithelial ovarian carcinoma patients may be included if responsive to neoadjuvant chemotherapy
- Multidisciplinary Committee evaluation confirming likelihood of complete cytoreduction
You will not qualify if you...
- Decline to consent to participate in the clinical trial
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) greater than 2
- Not eligible for major surgery
- Disease not confined to the abdomen or findings indicating optimal cytoreduction is not achievable (intestinal, biliary, or ureteral obstruction; diffuse small bowel or mesentery involvement)
- Known allergy or hypersensitivity to platinum-based chemotherapy agents
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Hodpsital General Universitario Gregorio Marañón
Madrid, Madrid, Spain, 28007
Actively Recruiting
Research Team
A
Alberto Lazaro, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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