Patients with a solid tumor treated by a chemotherapy and presented a cure report during more 7 days or a second report because of neutropénia grade 1-3 MedDRA version, level, term and classification is : C00-C75 (all solid tumors)
Conditions
Interventions
Trade Name: Lenograstim
Product Name: Granocyte
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: LENOGRASTIM
CAS Number: 135968091
Current Sponsor code: Chugaï-A
Sponsors
Centre François Baclesse
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age > and = 18 years - Patient treated by chemotherapy for a solid tumor for all ligne of treatments (adjuvant or metastatic) - Schema of chemotherapy every 21 days (days 8 allowed) - moderate neutropenia (grade 1-3) on the first day of cycle planned involved : first report cure during more 7 days or a second report - No less than 2 cures of chemotherapy planned at inclusion - Patient information and informed consent signed Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - hypersensibility known to G-CSF or to a composant - Neutropenia grade 4 or febril neutropenia on day of chemotherapy administration - Antecedent or evolutive psychiatric disease - impossibility to obtain inform consent - Pregnant, or breast-feeding or childbearing potential without efficace contraceptive - Adult patient private freedom or under tutelage - malign hematology tumor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the preservation of chemotherapy rythm under G-CSF : start the next cycle in planned date;Secondary Objective: comparate the tolerance of 2 administration schemas of G-CSF;Primary end point(s): - number of reported cures with growth factors | — |
Countries
France
Outcome results
None listed