Debulking Surgery for Ovarian CancerPhase 2NCT07229040
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 study testing cilastatine and tiosulfate in people with Debulking Surgery for Ovarian Cancer and Acute Kidney Injury, run by Hospital General Universitario Gregorio Marañon at 1 site in Spain.
Trial summary
To compare cilastatin vs thiosulfatein renal protection in patients undergoing debulking surgery with intraoperative hyperthermic intraperitoneal chemotherapy with cisplatin Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Debulking Surgery for Ovarian Cancer, Acute Kidney Injury
- What is being tested?
- cilastatine and tiosulfate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSpain
- Study dates
- 21 Feb 2025to 21 Oct 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hodpsital General Universitario Gregorio Marañón
Madrid, Madrid, 28007
Alberto Lazaro, PHD, +34914265115
alazaro10@gmail.com
About this study
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.
- Being tested
- cilastatine, tiosulfate
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cilastatineDrug
cilastatine 1.5 g
tiosulfateDrug
tiosulfate
| Study group | Role | What they receive |
|---|---|---|
| cilastatin | Experimental | cilastatina 1,5 g Receives: Drug: cilastatine |
| tiosulfate | Active comparator | tiosulfate Receives: Drug: tiosulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2025
- Study start21 Feb 2025
- Primary completion21 Oct 2028 (estimated)
- Study completion21 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Debulking Surgery for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Non inferiority study of cilastatin versus Thiosulfate
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario Gregorio Marañon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07229040
- Sponsor's protocol ID
- FIBHGM-ECNC001-2022
- Other IDs
- 2024-518854-18-00
- Status last verified
- Nov 2025
- First submitted
- 13 Nov 2025
- Last updated
- 14 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07229040
- Acronym / sponsor ID
- FIBHGM-ECNC001-2022
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Hospital General Universitario Gregorio MarañonUniversity, hospital or other
- Study start
- 21 Feb 2025 (actual)
- Primary completion
- 21 Oct 2028 (estimated)
- Study completion
- 21 Oct 2028 (estimated)
- First posted
- 14 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare cilastatin vs thiosulfatein renal protection in patients undergoing debulking surgery with intraoperative hyperthermic intraperitoneal chemotherapy with cisplatin
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Non inferiority study of cilastatin versus Thiosulfate
| Arm | Type | Receives |
|---|---|---|
| cilastatin | Experimental | Drug: cilastatinecilastatina 1,5 g |
| tiosulfate | Active comparator | Drug: tiosulfatetiosulfate |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cilastatinecilastatine 1.5 g | Drug | cilastatin |
| tiosulfatetiosulfate | Drug | tiosulfate |
Primary outcome
Percentage of patients with renal failure at 7 days
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cilastatine and tiosulfate in people with Debulking Surgery for Ovarian Cancer and Acute Kidney Injury, run by Hospital General Universitario Gregorio Marañon at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alberto Lazaro, PhD (+34914265115, alazaro10@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with renal failure at 7 days (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2025.