Clinical trial NCT05300828: Safety of Genexol PM and Carboplatin as First-line Therapy in Ovarian Cancer
Official title: An Observational Study to Evaluate the Safety of the Combination Therapy of Genexol PM and Carboplatin as First-line Therapy for Ovarian Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Cancer
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Samyang Biopharmaceuticals Corporation
First posted: 2022-03-29
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients at tertiary 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.


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

Primary outcomes:
measure: Number of participants showing adverse events
timeFrame: From the time of treatment start date through 30 days following cessation of treatment
Secondary outcomes:
measure: Neurotoxicity
timeFrame: From the time of treatment start date through 30 days following cessation of treatment
measure: other toxicity
timeFrame: From the time of treatment start date through 30 days following cessation of treatment
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Ajou University School of Medicine
Study officials:
affiliation: Seoul National University Hospital
name: Hee Seung Kim
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.