SODIUM THIOSULFATE for Peritoneal carcinomatosis|Peritoneal metastases

Inclusion criteria

• {"criterion_text":"- Age: adult patients from 18-75 years"}
• {"criterion_text":"- Sex: Male/Female"}
• {"criterion_text":"- Eastern Cooperative Oncology Group Performance status (ECOG PS) # 2"}
• {"criterion_text":"- General situation of the patient: patient suitable for major surgery, with values of creatinine, bilirubin, blood series in a range close to normal (Hb>10g/dl, leucos >3000/ml, neutrals >1000/ml, platelets >100,000 /ml)."}
• {"criterion_text":"- Patients evaluated in the Anesthesia office and considered suitable for the intervention"}
• {"criterion_text":"- Signed informed consent"}
• {"criterion_text":"- Disease confined to the abdomen: CRS+HIPEC is not contemplated in patients with lung or bone metastases, etc."}
• {"criterion_text":"- Evaluation in a Multidisciplinary Committee: radiological PCI is performed and it is estimated possibilities of complete cytoreduction, indicating CRS + HIPEC."}

Exclusion criteria

• {"criterion_text":"- Non-acceptance to participate in the clinical trial."}
• {"criterion_text":"- ECOG PS > 2."}
• {"criterion_text":"- Not suitable for major surgery."}
• {"criterion_text":"- Disease not limited to the abdomen or with signs that it cannot be optimally cytoreduced (intestinal obstruction, biliary obstruction, ureteral obstruction, diffuse involvement of the small intestine or mesentery)."}
• {"criterion_text":"- Allergy to platinum."}
• {"criterion_text":"- Patients with a neurological history who in the investigator's opinion are at risk of seizures associated with imipenem/cliastatin treatment."}

Primary endpoints

• {"endpoint_text":"- Percentage of patients with renal failure at 7 days* (if there is renal damage, follow-up until postoperative day 14) measured through creatinine values and the KDIGO classification. Renal failure is defined as an increase in serum creatinine of 1.5 to 1.9 times baseline, or an increase in serum creatinine by #0.3 mg/dL (#26.5 μmol/L), or a decrease in urine output <0.5 mL/kg/hour for 6 to 12 hours.","definition_or_measurement_approach":"Measured through creatinine values and KDIGO classification; renal failure defined as increase in serum creatinine of 1.5–1.9× baseline, or increase by ≥0.3 mg/dL (≥26.5 μmol/L), or urine output <0.5 mL/kg/hour for 6–12 hours; assessed at 7 days (if renal damage, follow-up to day 14)."}

Secondary endpoints

• {"endpoint_text":"- Differences in plasma pharmacokinetic variables of cisplatin during the HIPEC procedure between cilastatin-treated and thiosulfate-treated patients","definition_or_measurement_approach":"Plasma pharmacokinetic variables of cisplatin measured during HIPEC; comparison between treatment arms."}
• {"endpoint_text":"- Percentage of patients experiencing serious adverse events, adverse events related to study treatment, and adverse events occurring during the study.","definition_or_measurement_approach":"Collection and tabulation of adverse events and serious adverse events during study follow-up (AE attribution to study treatment noted)."}
• {"endpoint_text":"- Comparison of ARF in patients with cilastatin or thiosulfate with a total follow-up of 14 days","definition_or_measurement_approach":"Acute renal failure (ARF) comparison between arms over 14-day follow-up period."}
• {"endpoint_text":"- Comparison of urinary H202 values between patients who suffer from DR and patients who do not suffer from it.","definition_or_measurement_approach":"Urinary H2O2 (H202) measurement and comparison between patients with renal damage (DR) and those without."}
• {"endpoint_text":"- Comparison of urinary H202 values between patients who suffer DR and patients who do not.","definition_or_measurement_approach":"Same as above (urinary H2O2 comparisons between patients with and without renal damage)."}
• {"endpoint_text":"- Comparison of preoperative, intraoperative and postoperative factors between patients who suffer from kidney damage and patients who do not.","definition_or_measurement_approach":"Assessment and comparison of perioperative factors associated with kidney damage."}
• {"endpoint_text":"- Comparison of urinary FasL between patients with renal damage and patients without.","definition_or_measurement_approach":"Measurement of urinary FasL and comparison between patients with and without renal damage."}

Spain

Latest Decision Or Authorization Date

13-05-2025

Number Of Sites

1

Number Of Participants

90

Primary sponsor

Full Name

Fundacion Para La Investigacion Biomedica Del Hospital Gregorio Maranon

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Spain