NCT07229040 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 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Hospital General Universitario Gregorio Marañon |
| Condition | Debulking Surgery for Ovarian Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2025-02-21 |
| Primary Completion | 2028-10-21 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 90 participants in total. It began in 2025-02-21 with a primary completion date of 2028-10-21.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To compare cilastatin vs thiosulfatein renal protection in patients undergoing debulking surgery with intraoperative hyperthermic intraperitoneal chemotherapy with cisplatin
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07229040 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 75 Years, studying Debulking Surgery for Ovarian Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07229040 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07229040 currently recruiting?
Yes, NCT07229040 is actively recruiting participants. Contact the research team at alazaro10@gmail.com for enrollment information.
Where is the NCT07229040 trial being conducted?
This trial is being conducted at Madrid, Spain.
Who is sponsoring the NCT07229040 clinical trial?
NCT07229040 is sponsored by Hospital General Universitario Gregorio Marañon. The trial plans to enroll 90 participants.
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