Safety of Genexol PM and Carboplatin as First-line Therapy in Ovarian Cancer

Completed

• Conditions: Ovarian Cancer
• Interventions: Drug: Genexl PM

• Registration Number: NCT05300828
• Lead Sponsor: Seoul National University Hospital

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-19
• Study First Submitted: 2022-03-19
• Study First Submitted QC: 2022-03-19
• Study First Posted: 2022-03-29
• Primary Completion: 2022-04-30
• Study Completion: 2022-12-31
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-23
• Last Update Posted: 2023-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 600

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Genexol PM	Genexl PM	Genexol PM/carboplatin combination treatment is performed as an adjuvant treatment after cytoreductive surgery for newly diagnosed ovarian cancer.

Primary Outcome Measures

Name	Time	Method
Number of participants showing adverse events	From the time of treatment start date through 30 days following cessation of treatment	Number of any adverse event assessed based on CTCAE 4.0

Secondary Outcome Measures

Name	Time	Method
Neurotoxicity	From the time of treatment start date through 30 days following cessation of treatment	Number of participants showing grade 3/4 neurotoxicity assessed based on CTCAE 4.0
other toxicity	From the time of treatment start date through 30 days following cessation of treatment	Number of participants showing grade 3/4 any toxicity assessed based on CTCAE 4.0

Trial Locations

Locations (1)

Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Ajou University School of Medicine; 🇰🇷 Suwon, Korea, Republic of