glioblastoma of new diagnosis MedDRA version: 9.1 Level: LLT Classification code 10018336
Conditions
Interventions
Trade Name: TEMODAL*1FL 20CPS 100MG
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Temozolomide
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Trade
Sponsors
ISTITUTO NEUROLOGICO "CARLO BESTA"
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: * Newly diagnosed supra-tentorial glioblastoma, surgically resected * Radiologically proved surgical resection of the tumor mass * Age between 18 and 65 years * Karnofski Performance Status ≥ 70 * Bone marrow, liver and kidney standard functionality * No concomitant infections * Life expectancy > 12 weeks * Written informed consent 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: * Brain neoplasia for which histological diagnosis is not available * Newly diagnosed glioblastoma, obtained by biopsy * Glioblastoma with dissemination subependimal * Tissue histology not available * Age > 65 and <18-aa * Karnofski Performance Status <70 * Severely impaired bone marrow function, liver, kidney * Co-infected * Pregnancy * Pregresso chemotherapy and / or radiotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the study is to evaluate if ipofractionated stereotactic radiotherapy associated with concomitant and adjuvant temozolomide chemotherapy has a statistically significant advantage in prolonging Progression Free Survival (PFS) when compared to the standard treatment (Stupp protocol).;Secondary Objective: Toxicity, PFS, Median Survival Time, local control of the tumor and overall survival; neurological toxicity. Tumor response will be assessed on MRI images after 2 months and every 3 months after that.;Primary end point(s): The primary endpoint of the study is evaluation of percentage of patients desease free at 12 months. | — |
Countries
Italy
Outcome results
None listed