Status:
UNKNOWN
Efficacy of Neoadjuvant Hyperthermic Intraperitoneal Chemotherapy in Advanced High-grade Serous Ovarian Cancer (the NHIPEC Trial)
Lead Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Conditions:
Hyperthermic Intraperitoneal Chemotherapy
Neoadjuvant Chemotherapy
Eligibility:
FEMALE
17-70 years
Phase:
PHASE2
Brief Summary
Background: Neoadjuvant chemotherapy (NACT) is an important treatment option for patients with ovarian cancer. Although intravenous NACT can improve optimal resection rates and decrease surgical morbi...
Eligibility Criteria
Inclusion
- International Federation of Gynecology and Obstetrics(FIGO) stage IIIC-IVA, HGSOC
- Patients with Fagotti score ≥8
- Adequate kidney function (blood creatinine 58-96 µmol/L)
- Adequate haematological function (haemoglobin ≥110g/L, leucocytes ≥4.0×109/L, neutrophils ≥2.0×109/L, platelets≥100×109/L)
- Adequate liver function (serum total bilirubin 3.4-22.2µmol/L, alanine aminotransferase (ALT) 7-40U/L, aspartate aminotransferase (AST) 13-35U/L, AST/ALT ≤1.5)
- World Health Organization(WHO) score 0-2
Exclusion
- Patients who had received chemotherapy, radiotherapy or any kind of targeted therapy.
- Patients with complete intestine obstruction.
- Expected life span ≤8 weeks.
- Complicated with any other known malignancies.
- Patients with poor cardiopulmonary function, which would limit compliance with study requirements.
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05246020
Start Date
December 1 2020
End Date
December 1 2024
Last Update
February 18 2022
Active Locations (1)
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1
Sun Yat-sen Memorial Hospital
Guangzhou, Other (Non U.s.), China, 510000