Elderly (>65 years of age) patients with newly diagnosed, and histopathologically confirmed, glioblastoma multiforme (GBM, WHO grade IV) , who have had prior surgery/biopsy at diagnosis and who are not deemed suitable by their treating physician to receive the standard radiotherapy regimen (60 Gy / 30 fractions over 6 weeks) in combination with temozolomide. MedDRA version: 16.0 Level: PT Classification code 10018337 Term: Glioblastoma multiforme System Organ Class: 10029104 - Neoplasms benign,
Conditions
Interventions
Trade Name: TEMODAL 5 mg hard capsules
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: TEMOZOLOMIDE
CAS Number: 85622931
Concentration unit: mg milligram(s)
Concentration type: equal
Concentra
Sponsors
EORTC European Organisation for Research and Treatment of Cancer
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must fulfill all of the following criteria to be eligible for admission to the study: 1. Histopathologically confirmed newly diagnosed glioblastoma multiforme (GBM, WHO grade IV). The histological diagnosis must have been made after biopsy or neurosurgical tumour resection. 2. Initial surgery/biopsy at diagnosis performed 65 years. 4. Patient is not deemed suitable by the treating physician to receive the standard radiotherapy regimen (60 Gy / 30 fractions over 6 weeks) in combination with temozolomide. 5. ECOG performance status of 0, 1 or 2. 6. Patient may have received and continue to receive corticosteroids, but s/he have to be on a stable or decreasing dose for at least 14 days prior to randomisation. 7. Patient has not received prior chemotherapy or radiotherapy. 8. Adequate hematological, renal and hepatic functions as defined by the following required laboratory values obtained within 14 days prior to randomisation: - Absolute granulocyte count (AGC) = 1.5 x 109/L (1,500 cells/mm3) - Platelet count = 100 x 109/L (100,000 cells/mm3) - Serum creatinine = 1.5 times the upper limit of normal - Total serum bilirubin = 1.5 times the upper limit of normal - ALT (SGPT) =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients who fulfill any of the following criteria are not eligible for admission to the study: 1. Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for = 5 years. 2. Patients with a serious active infection (such as a wound infection requiring parenteral antibiotics) at the time of randomisation or other serious underlying medical conditions that would impair the ability of the patient to receive protocol treatment. 3. Patients with any condition (e.g. psychological, geographical, etc.) that does not permit compliance with the protocol. 4. Patients with known hypersensitivity to temozolomide or compounds with similar chemical composition to temozolomide. 5. Patients who have had treatment with any investigational cancer drug prior to randomisation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the overall survival (OS) rates between short-course radiation therapy alone and shortcourse radiation therapy given together with concurrent and adjuvant temozolomide, in elderly (>65 years of age) patients with newly diagnosed glioblastoma multiforme (GBM, WHO grade IV) , who have had prior surgery/biopsy at diagnosis and who are not deemed suitable by their treating physician to receive the standard radiotherapy regimen (60Gy/30 fractions over 6 weeks) in combination with temozolomide.;Secondary Objective: • To compare progression-free survival (PFS) between the two arms. • To compare the nature, severity, and frequency of adverse events between the two arms. • To compare the quality of life between the two arms using the EORTC QLQ-C30 and the EORTC Brain Cancer Module (QLQ-BN20). • To conduct molecular correlative studies, as follows: - Mandatory - To collect tumour samples obtained at the time of disease diagnosis in order to determine the methylation status of the O6-methylguanine-DNA methyltransferase (MGMT) promoter. - Optional - To bank tumour samples obtained at the time of disease diagnosis for future studies aiming to correlate outcomes and response to treatment to the expression levels or genetic alterations at diagnosis of other scientifically justified markers, as considered appropriate.;Primary end point(s): The primary endpoint of this study is the overall survival (OS), which is defined as the time from randomisation to the time of death from any cause. | — |
Countries
Belgium, France, Germany, Italy, Netherlands
Contacts
Public ContactProject-Budget & Regulatory Dept
European Organisation for the Research and Treatment of Cancer (EORTC)
Outcome results
None listed