- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05300828
Safety of Genexol PM and Carboplatin as First-line Therapy in Ovarian Cancer
June 23, 2023 updated by: Hee Seung Kim, Seoul National University Hospital
An Observational Study to Evaluate the Safety of the Combination Therapy of Genexol PM and Carboplatin as First-line Therapy for Ovarian Cancer Patients
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.
Study Overview
Study Type
Observational
Enrollment (Estimated)
600
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Suwon, Korea, Republic of
- Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Ajou University School of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
Patients at tertiary hospital
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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.
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Every three weeks, after intravenous infusion of 260 mg/m2 for 3 hours, followed by carboplatin AUC 5 for 3 hours.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants showing adverse events
Time Frame: From the time of treatment start date through 30 days following cessation of treatment
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Number of any adverse event assessed based on CTCAE 4.0
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From the time of treatment start date through 30 days following cessation of treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neurotoxicity
Time Frame: From the time of treatment start date through 30 days following cessation of treatment
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Number of participants showing grade 3/4 neurotoxicity assessed based on CTCAE 4.0
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From the time of treatment start date through 30 days following cessation of treatment
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other toxicity
Time Frame: From the time of treatment start date through 30 days following cessation of treatment
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Number of participants showing grade 3/4 any toxicity assessed based on CTCAE 4.0
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From the time of treatment start date through 30 days following cessation of treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Hee Seung Kim, Seoul National University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 19, 2015
Primary Completion (Actual)
April 30, 2022
Study Completion (Actual)
December 31, 2022
Study Registration Dates
First Submitted
March 19, 2022
First Submitted That Met QC Criteria
March 19, 2022
First Posted (Actual)
March 29, 2022
Study Record Updates
Last Update Posted (Actual)
June 26, 2023
Last Update Submitted That Met QC Criteria
June 23, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Ovarian Neoplasms
- Carcinoma, Ovarian Epithelial
Other Study ID Numbers
- GENEXOL PM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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