Cilastatin versus thiosulfate for protecting kidneys during ovarian cancer debulking with cisplatin HIPEC
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.
This trial tests whether cilastatin works as well as thiosulfate at protecting the kidneys in adult women having debulking surgery with intraoperative cisplatin HIPEC.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Hospital General Universitario Gregorio Marañon Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Madrid, Madrid) |
| Trial ID | NCT07229040 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adult women aged 18–75 who are eligible for cytoreductive surgery with cisplatin HIPEC, are fit for major surgery, and have near-normal baseline blood counts, liver tests, and creatinine are the intended participants.
Not a fit: Patients who are not surgical candidates, have significant distant metastases outside the abdomen, or have poor baseline kidney function are unlikely to benefit from joining this trial.
Why it matters
Potential benefit: If successful, the intervention could reduce cisplatin-related kidney injury and make HIPEC safer for patients needing debulking surgery.
How similar studies have performed: Sodium thiosulfate has prior clinical use and evidence for reducing cisplatin toxicity, whereas cilastatin is less established for this purpose, making this head-to-head comparison partly novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Madrid, Madrid
- Hodpsital General Universitario Gregorio Marañón — Madrid, Madrid, Spain (Recruiting)
Study contacts
- Study coordinator: Alberto Lazaro, PhD
- Email: alazaro10@gmail.com
- Phone: +34914265115
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.