Status:
UNKNOWN
Comparative Effectiveness of HIPEC Following Interval Debulking Surgery in Patients With Advanced-stage Ovarian Cancer
Lead Sponsor:
Ajou University School of Medicine
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
19+ years
Phase:
NA
Brief Summary
Ovarian cancer is a lethal malignancy and reported as a fifth leading cause of death in all age in the developed country. Most of the ovarian cancer patients are diagnosed at advanced stages due to an...
Detailed Description
GOG 172 trial showed a dramatic improvement of overall survival in patients with stage III disease treated with intraperitoneal cisplatin and paclitaxel compared with those with intravenous administra...
Eligibility Criteria
Inclusion
- patients histologically diagnosed with EOC (epithelial ovarian cancer), fallopian tubal cancer or primary peritoneal cancer.
- patients treated with neoadjuvant chemotherapy (NAC) followed by interval debulking surgery due to expected suboptimal residual disease at the time of primary surgery.
- patients who had diagnostic laparoscopy before NAC and confirmed with tumor burden, Fagotti score ≥8.
- ECOG performance status (0\~2)
- lab findings Bone marrow function : ANC\>1,500/mm3, Platelet \>100,000/mm3, Hemoglobin\>10.0g/dl Kidney function : creatinine\<1.25xUNL Liver function: AST, ALT\< x1.5UNL, bilirubin\<1.5mg/dl
- Live expenctancy \> 6 month
- Age \> 19 years old
Exclusion
- Patients with treated with primary debulking surgery
- Patients with double primary cancer ( exception: patients with early breast cancer or endometrial cancer that will not affect the clinical course of ovarian cancer)
- Patients with pregnant or breast feeding
Key Trial Info
Start Date :
October 26 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2022
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT03448354
Start Date
October 26 2017
End Date
July 1 2022
Last Update
July 5 2019
Active Locations (1)
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1
Ajou University Hospital
Suwon, Gyeonggi-do, South Korea, 16499