Actively Recruiting
A Double-blind Non Inferiority Clinical Trial to Compare the Nephroprotection of Cilastatin 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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing two drugs, cilastatin and thiosulfate, to see which better protects the kidneys in female patients undergoing debulking surgery combined with intraoperative hyperthermic intraperitoneal chemotherapy (HIPEC) using cisplatin. This phase 2, double-blind, randomized clinical trial evaluates whether cilastatin is not less effective than thiosulfate in preventing kidney damage in this setting. Participants receive either 1.5 grams of cilastatin or thiosulfate during their debulking surgery with HIPEC. The study uses a triple-blind design to prevent bias and randomly assigns patients to one of the two treatment groups. The main focus is on kidney protection during and after this specialized chemotherapy procedure, which targets tumors in the abdomen. During the study, researchers monitor patients for kidney failure within the first seven days after surgery to measure the primary outcome. Patients are assessed for overall health and eligibility before surgery, and kidney function is carefully tracked. The total participant age range is 18 to 75 years, and only females diagnosed with ovarian cancer suitable for this surgery are included. The study runs until October 2028 with ongoing monitoring and evaluation.
CONDITIONS
Brief 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...
- 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 count values within or near normal ranges (hemoglobin >10 g/dL, leukocytes >3,000/mL, neutrophils >1,000/mL, platelets >100,000/mL)
- Evaluated and deemed fit for surgery by the Anesthesiology Department
- Disease confined to the abdomen with no distant metastases outside specific limited cases
- Signed informed consent
- Multidisciplinary Committee evaluation supporting feasibility of complete cytoreduction
You will not qualify if you...
- Lack of consent to participate
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) greater than 2
- Not eligible for major surgery
- Disease not confined to the abdomen or with findings indicating optimal cytoreduction is not achievable (e.g., intestinal, biliary, ureteral obstruction, or diffuse small bowel involvement)
- Known hypersensitivity to platinum-based chemotherapy agents
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Day of surgery and immediate recovery period
Participants undergo debulking surgery with intraoperative hyperthermic intraperitoneal chemotherapy (HIPEC) using cisplatin, receiving either cilastatin or thiosulfate as nephroprotection during the procedure.
1 surgery visit and immediate post-operative care
Duration - 7 days
Participants are monitored for kidney function and recovery following surgery and chemotherapy to assess nephroprotection effectiveness.
Daily visits or assessments for 7 days post-surgery
Trial Site Locations
Total: 1 location
1
Hodpsital General Universitario Gregorio Marañón
Madrid, Madrid, Spain, 28007
Actively Recruiting
Research Team
A
Alberto Lazaro, PhD
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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