NCT05300828

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 19, 2015

Completed
6.4 years until next milestone

First Submitted

Initial submission to the registry

March 19, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 29, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

June 26, 2023

Status Verified

June 1, 2023

Enrollment Period

6.5 years

First QC Date

March 19, 2022

Last Update Submit

June 23, 2023

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Neurotoxicity

    From the time of treatment start date through 30 days following cessation of treatment

  • other toxicity

    From the time of treatment start date through 30 days following cessation of treatment

Study Arms (1)

Genexol PM

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

Drug: Genexl PM

Interventions

Genexl PMDRUG

Every three weeks, after intravenous infusion of 260 mg/m2 for 3 hours, followed by carboplatin AUC 5 for 3 hours.

Genexol PM

Eligibility Criteria

Age18 Years+
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients at tertiary hospital

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Ajou University School of Medicine

Suwon, South Korea

Location

Related Publications (2)

  • 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.

    PMID: 28324920BACKGROUND

  • 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.

    PMID: 28028994BACKGROUND

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • Hee Seung Kim

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 19, 2022

First Posted

March 29, 2022

Study Start

October 19, 2015

Primary Completion

April 30, 2022

Study Completion

December 31, 2022

Last Updated

June 26, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)