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Neoadjuvant hyperthermic intraperitoneal chemotherapy in advanced serous ovairan cancer: a randomized phase II trial

Neoadjuvant hyperthermic intraperitoneal chemotherapy in advanced serous ovairan cancer: a randomized phase II trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000038173
Enrollment
Unknown
Registered
2020-09-12
Start date
2020-10-08
Completion date
Unknown
Last updated
2020-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ovarian cancer

Interventions

experimental group :hyperthermic intraperitoneal chemotherapy

Sponsors

Department of Gynecologic Oncology,Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) FIGO stage IIIC-IVA,high-grade serous ovarian cancer (HGSOC); 2) Aged 18-70 years; 3) Fagotti >= 8, indicates that patients cannot undergo R0 primary debulking surgery; patients cannot endure primary debulking surgery; 4) Normal kidney function( blood creatinine 58-96 µmol/L); 5)Normal blood test (HBG >= 110 g/L, WBC >= 4.0 x 10^9/L, NEU >= 2.0 x 10^9/L, platelet >= 100 x 10^9/L); 6) Normal liver function (TBIL 3.4-22.2 µmol/L,ALT 7-40 U/L, AST 13-35 U/L AST/ALT <= 1.5); 7)World Health Organization performance-status score(WHO score) 0-2.

Exclusion criteria

Exclusion criteria: 1) Previous chemotherapy/radiotherapy/targeted therapy; 2) Complete intestine obstruction; 3) Expected life span <= 8 weeks; 4) Diagnosis of any other malignancy; 5) Poor cardiopulmonary function.

Design outcomes

Primary

MeasureTime frame
chemotherapy response score CRS;

Secondary

MeasureTime frame
progression free survival;overall survival;rate of residual 0 resection;adverse effect of HIPEC;

Countries

China

Contacts

Public ContactJing Li

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

lijing228@mail.sysu.edu.cn+86 15915893493

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 13, 2026