Clinical trial · Observational
Study on Neutropenia Induced by Adjuvant Paclitaxel/Carboplatin Chemotherapy in Patients With Epithelial Ovarian Cancer
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
NCT01680575CI-TRIAL-00027908unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Epithelial Ovarian Cancer | Ovarian Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- 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.
- label
- 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.
Primary outcomes (1)
- measure
- Risk prediction model for grade 3-4 chemotherapy induced neutropenia
- timeFrame
- 1 year
Secondary outcomes (1)
- measure
- The association between mannose-binding lectin 2 gene SNP and neutropenia
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.