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

Sponsor

Asan Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT01680575

Collaborator

(none)

750

Enrollment

Location

67.9

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Epithelial Ovarian Cancer

Study Design

Study Type:

Observational

Anticipated Enrollment :

750 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Development of a Risk Model Predicting Chemotherapy-induced Grade 3-4 Neutropenia by Paclitaxel/Carboplatin in Epithelial Ovarian Cancer: Prospective Observational Study for Model Development and Retrospective Study for Validation of Developed Model

Study Start Date :

Sep 1, 2012

Anticipated Primary Completion Date :

May 1, 2018

Anticipated Study Completion Date :

May 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
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.
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.

Outcome Measures

Primary Outcome Measures

Risk prediction model for grade 3-4 chemotherapy induced neutropenia [1 year]

Secondary Outcome Measures

The association between mannose-binding lectin 2 gene SNP and neutropenia [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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