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.
NCT ID: NCT07229040
Last Updated: 2025-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
90 participants
INTERVENTIONAL
2025-02-21
2028-10-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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cilastatin
cilastatina 1,5 g
cilastatine
cilastatine 1.5 g
tiosulfate
tiosulfate
tiosulfate
tiosulfate
Interventions
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cilastatine
cilastatine 1.5 g
tiosulfate
tiosulfate
Eligibility Criteria
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Inclusion Criteria
Sex: female. Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 2. General condition: patients eligible for major surgery, with creatinine, bilirubin, and blood count values within or close to the normal range (Hb \>10 g/dL, leukocytes \>3,000/mL, neutrophils \>1,000/mL, platelets \>100,000/mL).
Patients evaluated by the Anesthesiology Department and deemed fit for surgery. Signed informed consent. Disease confined to the abdomen: CRS + HIPEC is not indicated in patients with pulmonary, bone, or other distant metastases. Patients with limited hematogenous metastases to the spleen or liver may be considered. Patients with regional or distant intra-abdominal lymphatic dissemination may also be considered, provided complete resection is feasible. FIGO stage IVA epithelial ovarian carcinoma at presentation, due to pleural effusion with mediastinal lymph node or splenic metastases, is an indication for neoadjuvant chemotherapy; if response is achieved, CRS + HIPEC may subsequently be considered.
Multidisciplinary Committee evaluation: radiological PCI is assessed, and the likelihood of achieving complete cytoreduction is estimated to determine the indication for CRS + HIPEC.
Exclusion Criteria
Known hypersensitivity to platinum-based agents.
18 Years
75 Years
FEMALE
No
Sponsors
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Hospital General Universitario Gregorio Marañon
OTHER
Responsible Party
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Locations
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Hodpsital General Universitario Gregorio Marañón
Madrid, Madrid, Spain
Countries
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Central Contacts
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Facility Contacts
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Alberto Lazaro, PHD
Role: primary
Role: backup
Other Identifiers
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2024-518854-18-00
Identifier Type: CTIS
Identifier Source: secondary_id
FIBHGM-ECNC001-2022
Identifier Type: -
Identifier Source: org_study_id
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