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Clinical trial

An Observational Study to Evaluate the Safety of the Combination Therapy of Genexol PM and Carboplatin as First-line Therapy for Ovarian Cancer Patients

ID
Name
GENEXOL PM
Description
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 ovarian cancer patients compared to conventional paclitaxel/carboplatin combination therapy. Therefore, we will compare the prospective cohort with a historical comparison with patients administered paclitaxel/carboplatin and paclitaxel/carboplatin/bevacizumab combination therapy.
Trial arms
Trial start
2015-10-19
Estimated PCD
2022-04-30
Trial end
2022-12-31
Status
Completed
Treatment
Genexl PM
Every three weeks, after intravenous infusion of 260 mg/m2 for 3 hours, followed by carboplatin AUC 5 for 3 hours.
Arms:
Genexol PM
Size
600
Primary endpoint
Number of participants showing adverse events
From the time of treatment start date through 30 days following cessation of treatment
Eligibility criteria
Inclusion Criteria: * 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 Criteria: * 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
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 600, 'type': 'ESTIMATED'}}
Updated at
2023-06-26

1 organization

1 product

1 indication

Organization
Seoul National University Hospital
Product
Genexl PM
Indication
Ovarian Cancer