Study on Neutropenia Induced by Adjuvant Paclitaxel/Carboplatin Chemotherapy in Patients With Epithelial Ovarian Cancer

NCT ID: NCT01680575

Last Updated: 2017-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

750 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-30

Study Completion Date

2018-05-31

Brief Summary

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To develop a robust prediction model to predict the occurrence of grade 3-4 neutropenia induced by adjuvant paclitaxel/carboplatin chemotherapy in patients with epithelial ovarian cancer and to validate this model.

Detailed Description

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Conditions

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Epithelial Ovarian Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Training cohort

This cohort is a prospective cohort to develop a risk prediction model. This cohort include patients who underwent staging operation or debulking operation for epithelial ovarian cancer and are planned to receive ajuvant chemotherapy with paclitaxel/carboplatin up to 6 cycles.

No interventions assigned to this group

Validation cohort

This is a retrospective cohort for validation of a risk prediction model developed using training cohort.

This is consisted with 600 patients with epithelial ovarian cancer who received adjuvant chemotherapy with paclitaxel/carboplatin after staging operation or debulking operation.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients with FIGO stage I-IV epithelial ovarian cancer after staging or debulking surgery
* Patients who is planned to receive (prospective cohort) ro who received (retrospective cohort) adjuvant chemotherapy with paclitaxel and carboplatin
* Patients who have signed approved informed consent

Exclusion Criteria

* Uncontrolled medical disease
* Active infectious disease
* Previous pelvic radiation therapy
* Previous chemotherapy (prospective cohort)
* Patients with disease which can cause neutropenia
* Patients who will receive other targeted therapy or immunotherapy during adjuvant therapy (prospective cohort).
* Pregnant or lactating woman
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jeong-Yeol Park

Clinical Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeong-Yeol Park, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

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Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jeong-Yeol Park, M.D., Ph.D.

Role: CONTACT

82-2-3010-3646

Facility Contacts

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Jeong-Yeol Park, M.D., Ph.D.

Role: primary

Other Identifiers

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NEPACA-OVCA

Identifier Type: -

Identifier Source: org_study_id

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