An Observational Study to Evaluate the Safety of the Combination Therapy of Genexol PM and Carboplatin as First-line Therapy for Ovarian Cancer Patients
Sponsor study identifier
observational
600
1 country
1
Study Start
October 19, 2015
Actual (reported)Primary Completion
April 30, 2022
Actual (reported)Study Completion
December 31, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 19, 2015
Actual (reported)March 19, 2022
Actual (reported)March 29, 2022
Actual (reported)April 30, 2022
Actual (reported)December 31, 2022
Actual (reported)Number of participants showing adverse events
Number of any adverse event assessed based on CTCAE 4.0
From the time of treatment start date through 30 days following cessation of treatment
Neurotoxicity
From the time of treatment start date through 30 days following cessation of treatment
other toxicity
From the time of treatment start date through 30 days following cessation of treatment
Genexol PM/carboplatin combination treatment is performed as an adjuvant treatment after cytoreductive surgery for newly diagnosed ovarian cancer.
Every three weeks, after intravenous infusion of 260 mg/m2 for 3 hours, followed by carboplatin AUC 5 for 3 hours.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients at tertiary hospital
Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Ajou University School of Medicine
Suwon, South Korea
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.
Hee Seung Kim
Seoul National University Hospital
First Submitted
March 19, 2022
First Posted
March 29, 2022
Study Start
October 19, 2015
Actual (reported)Primary Completion
April 30, 2022
Actual (reported)Contact the study team to confirm eligibility.
Study Completion
December 31, 2022
Actual (reported)Last Updated
June 26, 2023
Record last verified: 2023-06
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Source: ClinicalTrials.gov.
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