Safety of Genexol PM and Carboplatin as First-line Therapy in Ovarian Cancer
NCT ID: NCT05300828
Last Updated: 2023-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
600 participants
OBSERVATIONAL
2015-10-19
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Genexol PM
Genexol PM/carboplatin combination treatment is performed as an adjuvant treatment after cytoreductive surgery for newly diagnosed ovarian cancer.
Genexl PM
Every three weeks, after intravenous infusion of 260 mg/m2 for 3 hours, followed by carboplatin AUC 5 for 3 hours.
Interventions
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Genexl PM
Every three weeks, after intravenous infusion of 260 mg/m2 for 3 hours, followed by carboplatin AUC 5 for 3 hours.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Samyang Biopharmaceuticals Corporation
INDUSTRY
Seoul National University Hospital
OTHER
Responsible Party
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Hee Seung Kim
Professor
Principal Investigators
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Hee Seung Kim
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Ajou University School of Medicine
Suwon, , South Korea
Countries
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References
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Lee SW, Kim YM, Cho CH, Kim YT, Kim SM, Hur SY, Kim JH, Kim BG, Kim SC, Ryu HS, Kang SB. An Open-Label, Randomized, Parallel, Phase II Trial to Evaluate the Efficacy and Safety of a Cremophor-Free Polymeric Micelle Formulation of Paclitaxel as First-Line Treatment for Ovarian Cancer: A Korean Gynecologic Oncology Group Study (KGOG-3021). Cancer Res Treat. 2018 Jan;50(1):195-203. doi: 10.4143/crt.2016.376. Epub 2017 Mar 21.
Lee SW, Kim YM, Kim YT, Kang SB. An open-label, multicenter, phase I trial of a cremophor-free, polymeric micelle formulation of paclitaxel combined with carboplatin as a first-line treatment for advanced ovarian cancer: a Korean Gynecologic Oncology Group study (KGOG-3016). J Gynecol Oncol. 2017 May;28(3):e26. doi: 10.3802/jgo.2017.28.e26. Epub 2016 Dec 19.
Other Identifiers
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GENEXOL PM
Identifier Type: -
Identifier Source: org_study_id
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