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| Name | Class |
|---|---|
| Samyang Biopharmaceuticals Corporation | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Genexol PM | Genexol PM/carboplatin combination treatment is performed as an adjuvant treatment after cytoreductive surgery for newly diagnosed ovarian cancer. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Genexl PM | Drug | Every three weeks, after intravenous infusion of 260 mg/m2 for 3 hours, followed by carboplatin AUC 5 for 3 hours. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Neurotoxicity | Number of participants showing grade 3/4 neurotoxicity assessed based on CTCAE 4.0 | From the time of treatment start date through 30 days following cessation of treatment |
| other toxicity |
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Inclusion Criteria:
Exclusion Criteria:
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Patients at tertiary hospital
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| Name | Affiliation | Role |
|---|---|---|
| Hee Seung Kim | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Ajou University School of Medicine | Suwon | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28324920 | Background | 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. | |
| 28028994 |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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Number of participants showing grade 3/4 any toxicity assessed based on CTCAE 4.0
| From the time of treatment start date through 30 days following cessation of treatment |
| Background |
| 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. |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |