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

Asan Medical Center

Status: Unknown

Conditions: Epithelial Ovarian Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT01680575

NEPACA-OVCA

Details and patient eligibility

About

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.

Enrollment: 750 estimated patients

Sex: Female

Ages: 20 to 80 years old

Volunteers: No 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

Trial design

750 participants in 2 patient groups

Training cohort

Description:

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

Description:

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.