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RecruitingNCT07229040Updated Nov 14, 2025

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.

A Phase 2 interventional study of cilastatine and tiosulfate in Debulking Surgery for Ovarian Cancer and Acute Kidney Injury, sponsored by Hospital General Universitario Gregorio Marañon. Recruiting at 1 site in Spain. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-11-14.

Sponsored by Hospital General Universitario Gregorio Marañon · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
Female
01

Study summary

To compare cilastatin vs thiosulfatein renal protection in patients undergoing debulking surgery with intraoperative hyperthermic intraperitoneal chemotherapy with cisplatin

Read the detailed description

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.

02

Conditions studied

  • Debulking Surgery for Ovarian Cancer
  • Acute Kidney Injury

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03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.

04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    cilastatin

    cilastatina 1,5 g

    Drug: cilastatine

  • Active comparator
    tiosulfate

    tiosulfate

    Drug: tiosulfate

Interventions

  • Drugcilastatine

    cilastatine 1.5 g

  • Drugtiosulfate

    tiosulfate

05

What researchers measure

Primary outcomes

  1. Percentage of patients with renal failure at 7 days

    Percentage of patients with renal failure at 7 days (If renal impairment is present, follow-up continues until postoperative day 14), assessed based on serum creatinine levels and KDIGO classification criteria. Renal failure is defined as an increase in serum creatinine to 1.5-1.9 times the baseline value, or an increase in serum creatinine by ≥0.3 mg/dL (≥26.5 µmol/L), or a reduction in urine output to \<0.5 mL/kg/hour for 6 to 12 hours.

    Time frame: 7 days

06

Study locations

1 of 1 sites recruiting
  • Hodpsital General Universitario Gregorio Marañón
    Madrid, Madrid 28007, Spain
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07229040
Lead sponsor
Hospital General Universitario Gregorio Marañon
Responsible party
Sponsor
First posted
Nov 14, 2025
Start date
Feb 21, 2025
Primary completion
Oct 21, 2028 (estimated)
Completion
Oct 21, 2028 (estimated)
Last update
Nov 14, 2025

Study contacts

Alberto Lazaro, PhD
Contact
alazaro10@gmail.com
+34914265115

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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