PROPHYLACTIC TREATMENT FOR CHEMO-INDUCED NEUTROPENIA. USE OF G-CSF BIOSIMILAR (NIVESTIM(REGISTERED)) ACCORDING TO THE CHEMOTHERAPY CONTEXT: ADJUVANT VERSUS METASTATIC.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 1,160
- 试验地点
- 86
- 主要终点
- Percentage of Participants by Level of Importance of Factors Determining the Use of Nivestim
研究概览
简要总结
The aim of this study is to describe in real-life conditions the determinants of use of GCSF (Granulocyte Colony-Stimulating Factor) Nivestim® in primary or secondary prophylaxis and in patients receiving chemotherapy for solid tumour according to the chemotherapy context: adjuvant or metastatic setting.
详细描述
This is a longitudinal, observational, prospective, multicentre, cohort study, conducted in France among a representative sample of public and/or private hospital-based oncologists.
Data will be collected by the investigator during three visits using data available in the patient medical record and obtained from patient questioning and clinical examination performed during the consultations:
- Baseline visit: prescription of Nivestim®.
- Follow-up visit: during the first cycle of chemotherapy after the first course of Nivestim®.
- Final visit: after the last cycle of chemotherapy or 16-18 weeks after inclusion.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged at least 18 years, seen by the oncologist for chemotherapy for solid tumour.
- •Patients for whom the oncologist has decided the initiation of G-CSF biosimilar treatment (Nivestim®) in primary or secondary prophylaxis.
- •Patients informed about the computer processing of their medical data and their right of access and correction.
排除标准
- •Patients with contraindication of use of Nivestim®.
- •Patients with haematological malignancy including Myelodysplasia and Chronic myeloid leukemia treated or untreated.
- •Patients participating or having participated in the previous month in a clinical trial.
- •Patients refusing to participate in this study.
结局指标
主要结局
Percentage of Participants by Level of Importance of Factors Determining the Use of Nivestim
时间窗: Inclusion visit (Week 1)
The factors which determined the use of Nivestim among participants included participant's sex, young participant, elderly participant, past history of infection, comorbidities, life expectancy, past history of febrile neutropenia and severe neutropenia, occupational activity, family activity and other important criteria. Percentage of participants were categorized based upon the level of importance under different categories which included very important, important, relatively important, not important and not applicable.
次要结局
- Number of Participants With Dose Reduction in Chemotherapy Due to Neutropenia(Follow-up visit (Week 3))
- Number of Participants With Delayed Administration of Chemotherapy Cycle Due to Neutropenia(Follow-up visit (Week 3))
- Change From Inclusion Visit in Disease Status as Measured by Number of Neutrophil Cells (Neutrophils), Platelet Count and Leukocyte Count at End of Study(Inclusion visit (Week 1), End of study visit (up to Week 19))
- Number of Participants With Unplanned Discontinuation of Chemotherapy at the End of Study Visit(End of study visit (up to Week 19))
- Number of Participants With Neutropenia and Febrile Neutropenia(Follow-up visit (Week 3); End of study visit (up to Week 19))
- Change From Inclusion Visit in Disease Status as Measured by Participants Performance Status at End of Study(Inclusion visit (Week 1); End of study visit (up to Week 19))
- Number of Participants Who Continued Chemotherapy(Follow-up visit (Week 3); End of study visit ( up to Week 19))
- Number of Participants Who Discontinued Chemotherapy(Follow-up visit (Week 3); End of study visit ( up to Week 19))
- Number of Participants With Unplanned Discontinuation of Chemotherapy at Follow Up Visit(Follow-up visit (Week 3))
- Number of Participants With Change in Chemotherapy Protocol at End of Study Visit(End of study visit (up to Week 19))
- Change From Inclusion Visit in Disease Status as Measured by Haemoglobin Level at End of Study Visit(Inclusion visit (Week 1), End of study visit (up to Week 19))
- Number of Participants Who Wished to Again Have Nivestim Treatment If Necessary(End of study visit (up to Week 19))
- Pain Experienced by Participant During Injection of Nivestim as Assessed by Pain at the Injection Site(End of study visit (up to Week 19))
- Number of Participants With Chemotherapy Satisfaction as Per Doctor Assessment After Chemotherapy Treatment(End of study visit (up to Week 19))
- Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)(Inclusion visit (Week 1) up to end of study visit (up to Week 19))