Status:
COMPLETED
Safety of Genexol PM and Carboplatin as First-line Therapy in Ovarian Cancer
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
Samyang Biopharmaceuticals Corporation
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Brief Summary
To evaluate the safety profile of Genexol PM combination with carboplatin for patients with newly diagnosed ovarian cancer. We hypothesized Genexol PM can be safely administered to newly diagnosed ova...
Eligibility Criteria
Inclusion
- Age over 18
- Patients consented to participate
- Pathologically diagnosed ovarian cancer FIGO stage IC-IVB
- ECOG 0-2
- Patients with an expected survival of 3 months or more
Exclusion
- History of paclitaxel or carboplatin hypersensitivity
- Inadequate bone marrow function (Neutrophil\<1500/mm3, Platelet \<100,000/mm3)
- Pregnancy or breast-feeding state
- Metachronous or synchronous malignancy
- Galactose intolerance, Lapp Lactase deficiency, or glucose-galactose malabsorption patients with genetic problems
- Other patients who were judged difficult to be included in this investigation by the investigator in charge
Key Trial Info
Start Date :
October 19 2015
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT05300828
Start Date
October 19 2015
End Date
December 31 2022
Last Update
June 26 2023
Active Locations (1)
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1
Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Ajou University School of Medicine
Suwon, South Korea