Modalities of G-CSF Zarzio® use in clinical practice in patients receiving cytotoxic chemotherapy regimens in which the rest period does not exceed 14 days for breast, lung, gastrointestinal cancers and lymphoma. (TOPAZE)

Study identification

• EU PAS number:
  EUPAS11465
• Study ID:
  18897
• Official title and acronym:
  Modalities of G-CSF Zarzio® use in clinical practice in patients receiving cytotoxic chemotherapy regimens in which the rest period does not exceed 14 days for breast, lung, gastrointestinal cancers and lymphoma. (TOPAZE)
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  This TOPAZE study is a French national, multicenter, prospective and descriptive, non-interventional study, in patients initiating Zarzio® treatment and receiving a cytotoxic chemotherapy in which the rest period does not exceed 14 days. Use of G-CSF (Granulocyte Colony Stimulating Factors) to prevent chemotherapy-induced febrile neutropenia (FN) was defined in the EORTC’s guidelines in 2006, updated in 2010: primary prophylaxis by G-CSF is recommended in patients receiving a chemotherapy regimen with high risk of FN (≥20%) or an intermediate risk (10–20%) associated with other risk factors, but also to maintain dose-dense or dose-intense chemotherapy in order to preserve survival benefits. However, there are no clear recommendations concerning chemotherapy regimens in which the rest period do not exceed 14 days. Today, a significant number of chemotherapy regimens are weekly or every two weeks administered, or three or four weeks administered, but with a rest period of less than 14 days.Besides, these chemotherapies are often associated with targeted therapies, and there are no specific recommendations in these situations.The main objective of this study is to describe Zarzio® modalities of clinical daily use in patients receiving chemotherapy regimens with a rest period no exceeding 14 days (≤ 14 days).Data will be collected from information available as routine practice: Demographic data, Description of tumoral disease, Medical history and comorbidity factors, Clinical evaluation, Concomitant medications, Patient laboratory data, Zarzio® treatment, Chemotherapy treatment, Adverse events.All data collected will be anonymized thus protecting patient's confidentiality.No interventional procedures or change to routine medical practice are required for
• Study status:
  Ongoing

Research institutions and networks

Institutions

Sandoz

Study timelines

Date when funding contract was signed

Actual: 05/01/2015

Study start date

Planned: 16/11/2015

Actual: 25/11/2015

Date of final study report

Planned: 29/03/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

SANDOZ

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable