Cilastatin versus thiosulfate for protecting kidneys during ovarian cancer debulking with cisplatin HIPEC

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a double-blind, phase 2 non-inferiority trial comparing cilastatin and thiosulfate as nephroprotective agents given around cytoreductive surgery with intraoperative hyperthermic intraperitoneal chemotherapy (HIPEC) using cisplatin. Adult female patients deemed fit for major surgery and meeting laboratory criteria are enrolled and receive one of the two interventions during the perioperative period. Kidney function and the occurrence of acute kidney injury will be followed around the time of surgery to determine whether cilastatin is not worse than thiosulfate. The trial is conducted at a single tertiary hospital center.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age: adult patients aged 18-75 years.

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:

* Lack of consent to participate in the clinical trial. Eastern Cooperative Oncology Group Performance Status (ECOG PS) \> 2. Not eligible for major surgery. Disease not confined to the abdomen, or with findings indicating that optimal cytoreduction is not achievable (e.g., intestinal obstruction, biliary obstruction, ureteral obstruction, or diffuse involvement of the small bowel or mesentery).

Known hypersensitivity to platinum-based agents.

Where it's running

• Hodpsital General Universitario Gregorio Marañón
  Madrid, Madrid, Spain Recruiting

Study contacts

• Study coordinator: Alberto Lazaro, PhD
• Email: alazaro10@gmail.com
• Phone: +34914265115

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.