Clinical trial NCT05877911: Effect of Sodium Thiosulfate on Nephrotoxicity of Cisplatin Intraperitoneal Heat-perfusion Chemotherapy
Official title: Effect of Sodium Thiosulfate on Nephrotoxicity of Cisplatin Intraperitoneal Heat-perfusion Chemotherapy: a Multi-center Prospective Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Epithelial Ovarian Cancer
Acute Kidney Injury Due to Circulatory Failure
Keywords: Epithelial Ovarian Cancer
Acute Kidney Injury
Hyperthermic Intraperitoneal Chemotherapy
Sodium thiosulfate
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
Collaborators: name: Yunnan Cancer Hospital
name: Qilu Hospital of Shandong University
First posted: 2023-05-26
Enrollment: 110
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients were randomly assigned to treatment group or control group by block randomisation in a 1:1 ratio.

Treatment group: Receive HIPEC using sodium thiouracil and hydration Control group: Receive HIPEC only using hydration.
Primary purpose: TREATMENT

Brief summary: Ovarian cancer is the most lethal malignancy of the female genital tract. Cytoreductive surgery combined with chemotherapy is the primary treatment for ovarian cancer, and radical tumor resection is an important means to improve the prognosis. However, even after complete tumor resection, 75% of patients with ovarian cancer still recur within 3 years after the initial treatment and eventually die from recurrence. In ovarian cancer, the lesions are located primarily in the peritoneal cavity. High-grade evidence demonstrates that the use of intraperitoneal hyperthermic chemotherapy (HIPEC) with cisplatin after cytoreductive surgery significantly improves the outcome in some patients with ovarian cancer. Currently, this is the only non-pharmacologic treatment that reduces both the risk of recurrence and death from ovarian cancer with a multi treatment. However, HIPEC with cisplatin can lead to acute kidney injury, and a serious complication that can seriously affect the short and long-term prognosis of patients. Sodium thiosulfate has previously been reported to reduce the incidence of acute kidney injury after HIPEC with cisplatin, but this finding has not been confirmed in a high-level study. Therefore, we propose a multi-center, prospective, open-label, randomized, controlled trial including 110 patients with ovarian cancer who received HIPEC with cisplatin, to evaluate whether sodium thiosulfate combined with hydration (55 patients in the trial group) can reduce the incidence of acute kidney injury after HIPEC with cisplatin compared with hydration alone (55 patients in the control group), and to provide high-level evidence for the rationale of using sodium thiosulfate for nephrotoxicity relief in cisplatin HIPEC.


Eligibility criteria: Inclusion Criteria:（The following conditions must be met at the same time）

* Patients treated with HIPEC with cisplatin.
* Estimated survival \> 12 weeks
* Age from 18 to 70 years
* Bone marrow reserve was well functioning. Leukocytosis ≥ 3.0×10\^9/L, neutrophilic granulocyte ≥ 1.5 × 10\^9/L, platelet count ≥ 100 × 10\^9/L, and hemoglobin ≥ 80 g/L.
* Organs work well. AST ≤ 2.5 × ULN, ALT ≤ 2.5 × upper limit of normal(ULN), total serum bilirubin ≤ 1.5 × ULN, and creatinine ≤ 1.5 × ULN
* ECOG score 0-1
* Patients voluntarily sign an informed consent form

Exclusion Criteria:（None of which was eligible）.

* Extensive abdominal adhesions
* HIPEC with Cisplatin for other medical conditions in the last 5 years.
* Receiving other drugs that cause kidney damage.
* Simultaneous use of amifotin for other diseases.
* Any situation of disease instability or potentially impact safety and adherence of patient.
* Chronic or acute nephropathy of any degree or other serious medical complications.

Primary outcomes:
measure: Calculate the incidence of acute kidney injury after HIPEC based on creatinine levels and 24-hour urine output according to KDIGO criteria.
timeFrame: Within one week after patients receive cisplatin-based HIPEC.
Secondary outcomes:
measure: Calculate the incidence of chronic kidney injury after HIPEC based on creatinine levels according to KDIGO criteria.
timeFrame: Through study completion, an average of 2 year
measure: Number of patients with sodium sulfate-related adverse events assessed by CTCAE v5.0.
timeFrame: 72 hours after sodium sulfate administration.
measure: Time from randomization to relapse or death（DFS）.
timeFrame: From date of randomisation to date of first recorded progression or death from any cause, whichever came first, assessed up to 5 years.
Other outcomes:
Locations:
Study officials:
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