Chemotherapy used in the treatment of primitive tumors of the central nervous system has a particularly important platelet toxicity compared to chemotherapy used for treatment of other tumors. Chemotherapy postponed for toxicity is often due to thrombocytopenia (TP). The TP and/or the other anomalies of coagulation, which can be spontaneous (Rogers, 2004) or induced (Gerber, 2006) can have dramatic consequences: * specifically neurological (intratumoral bleeding with particularly important neovascularization) with a functional aggravation and sometimes involvement of vital prognosis, * digestive (Garcia-Rodiguez, 2001) in patients receiving long term treatment with corticoids (potential gastric toxicity). The encouraging results from the EORTC/NCIC trial by Stupp (median survival among patients with newly diagnosed glioblastoma is 14.6 months with an estimated 5-year survival of 9, 8%), has changed the standard of care of these patients (Stupp et al., 2009). Patients with newly diagnosed, histologically confirmed glioblastoma receive radiotherapy (2 Gy given 5 days per week for 6 weeks, for a total of 60 Gy) plus continuous daily Temozolomide (75 mg per square meter of body-surface area per day, 7 days per week from the first to the last day of radiotherapy), followed by six cycles of adjuvant Temozolomide (TMZ) (150 to 200 mg per square meter for 5 days during each 28-day cycle). The Stupp regimen is currently the treatment of reference for glioblastoma and is used as a basis in various clinical studies with new agents. This study aims to evaluate Romiplostim for the treatment of TP secondary to initial TMZ chemotherapy of glioblastomas.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
CHRU de Lille, Hôpital Roger Salengro,Clinique de Neurochirurgie
Lille, France
Hôpital Neurologique Pierre Wertheimer, Lyon,
Lyon, France
AP-HM,Hôpital La Timone, AP-HM, Marseille
Marseille, France
AH-HP, Hôpital Pitié-Salpêtrière, Service de Neurologie 2
Paris, France
Proportion of patients receiving 100% of the planned TMZ dosage in the whole Stupp protocol. The primary endpoint will consider dose reduction and dose delay.
Time frame: one year
Incidence of serious adverse events according to CTCAE 4.0 criteria.
Time frame: one year
Incidence of delayed chemotherapy cycles and the incidence of chemotherapy cycles with dose reduction due to severe TP
Time frame: one year
Number and percentage of patients with TP of grade 3 or grade 4 after receiving Romiplostim.
Time frame: One year
Number and percentage of patients receiving platelets transfusion for TP
Time frame: one year
Incidence and type of adverse events linked to TP episodes during Romiplostim and Temozolomide combined treatment.
Time frame: one year
6 months Progression Free Survival:
Time frame: one year
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