An observational study in Ovarian Cancer, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-26.
Sponsored by Seoul National University Hospital · Observational
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.
2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.
This study's planned enrollment of 600 is above the median of 200 across 527 observational studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients at tertiary hospital
Exclusion Criteria:
Genexol PM/carboplatin combination treatment is performed as an adjuvant treatment after cytoreductive surgery for newly diagnosed ovarian cancer.
Drug: Genexl PM
Every three weeks, after intravenous infusion of 260 mg/m2 for 3 hours, followed by carboplatin AUC 5 for 3 hours.
Number of participants showing adverse events
Number of any adverse event assessed based on CTCAE 4.0
Time frame: From the time of treatment start date through 30 days following cessation of treatment
Neurotoxicity
Number of participants showing grade 3/4 neurotoxicity assessed based on CTCAE 4.0
Time frame: From the time of treatment start date through 30 days following cessation of treatment
other toxicity
Number of participants showing grade 3/4 any toxicity assessed based on CTCAE 4.0
Time frame: From the time of treatment start date through 30 days following cessation of treatment
Plan to share: No
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Seoul National University Hospital