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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Asan Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Jeong-Yeol Park, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01680575
First received: September 4, 2012
Last updated: September 8, 2012
Last verified: September 2012
  Purpose

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
Epithelial Ovarian Cancer

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • Risk prediction model for grade 3-4 chemotherapy induced neutropenia [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The association between mannose-binding lectin 2 gene SNP and neutropenia [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 750
Study Start Date: September 2012
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.


  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Training cohort (prospective cohort): Patients with epithelial ovarian cancer who underwent staging operation or debulking surgery at university hospital and who are planned to receive adjuvant chemotherapy with paclitaxel and carboplatin.

Validation cohort (retrospective cohort): Patients with epithelial ovarian cancer who received adjuvant chemotherapy with paclitaxel and carboplatin after staging operation or debulking operation.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01680575

Contacts
Contact: Jeong-Yeol Park, M.D., Ph.D. 82-2-3010-3646 catgut1-0@hanmail.net

Locations
Korea, Republic of
Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Jeong-Yeol Park, M.D., Ph.D.         
Sponsors and Collaborators
Asan Medical Center
Investigators
Principal Investigator: Jeong-Yeol Park, M.D., Ph.D. Asan Medical Center
  More Information

No publications provided

Responsible Party: Jeong-Yeol Park, Clinical Assistant Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01680575     History of Changes
Other Study ID Numbers: NEPACA-OVCA
Study First Received: September 4, 2012
Last Updated: September 8, 2012
Health Authority: Korea: Asan Medical Center Institutional Review Board

Keywords provided by Asan Medical Center:
Neutropenia
Paclitaxel
Carboplatin
Epithelial ovarian cancer

Additional relevant MeSH terms:
Neoplasms, Glandular and Epithelial
Neutropenia
Ovarian Neoplasms
Adnexal Diseases
Agranulocytosis
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Hematologic Diseases
Leukocyte Disorders
Leukopenia
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms
Carboplatin
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 23, 2014