Newly diagnosed patients with glioblastoma harbouring a methylated MGMT promoter MedDRA version: 18.1 Level: PT Classification code 10018336 Term: Glioblastoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Pharmaceutical Form:
INN or Proposed INN: TEMOZOLOMIDE
CAS Number: 85622-93-1
Trade Name: Cecenu
Pharmaceutical Form: Capsule
INN or Proposed INN: LOMUSTINE
CAS Number: 13010474
Concentration unit:
Sponsors
Medical Faculty, University of Bonn
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Written informed consent Patients have to be in a cognitive state that allows them to understand the rationale and necessity of study therapy and procedures. Newly diagnosed histologically proven GBM or gliosarcoma WHO Grad IV, histology confirmed by reference neuropathology (Insitute of Neuropathology, University of Bonn Medical Center, Prof. Dr. Pietsch). Histology obtained by complete resection, partial resection, open biopsy or stereotactic biopsy Methylated MGMT promoter in the tumor as determined by Oncomethylome (Amsterdam) using methylation-specific PCR Males or females 18-70 years of age, estimated life expectancy of at least 12 weeks Karnofsky Performance Score (KPS) = 70% Patient compliance and geographic proximity that allow adequate follow up Male and female patients with reproductive potential must use an approved contraceptive method (intrauterine device, birth control pills, or barrier device) during and for 3 months after the trial (Pearl index 1500/µl, platelets =100000/µl, haemoglobin = 10 g/dl Adequate liver function bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Prior malignancy (unless adequately treated carcinoma in situ of the cervix or nonmelanoma skin cancer), unless the prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsquent evidence of recurrence Prior chemotherapy, systemic or local treatment with DNA-damaging agents, tyrosine kinase inhibitors or anti-angiogenic agents for any cancer prior RT to the brain Concurrent administration of any other anti-tumor therapy not described in the protocol Allergy or other intolerability of temozolomide or CCNU Unable to undergo MRI Past medical history of diseases with poor prognosis, e.g. severe coronary heart disease, heart failure (NYHA III/IV), severe and poorly controlled diabetes, immune deficiency, residual deficits after stroke, severe mental retardation or other serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator) Known HIV infection, active Hepatitis B or C infection Any active infection (at the discretion of the investigator) Female patients that are pregnant or breastfeeding Patients with reproductive potential who do not accept to use contraception during the trial and 3 months thereafter Treatment in another clinical trial with therapeutic intervention or use of any other investigational agent within the 30 days before enrolment Any psychological, cognitive, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up scheduled visits (at the discretion of investigator)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This phase III trial determines whether combined Cecenu and Temozolomide chemotherapy plus standard radiotherapy is superior to TMZ monochemotherapy plus standard radiotherapy alone in patients with newly diagnosed mMGMT GBM patients regarding overall survival. ;Secondary Objective: Secondary objectives are to determine whether combined CCNU/TMZ/RT therapy is superior to standard TMZ/RT therapy regarding progression-free survival and time to treatment failure as well as to determine acute and late toxicity of CCNU/TMZ therapy including its effects such as the delay of subsequent courses due to acute toxicity.;Primary end point(s): Overall survival (OS) as measured from the day of randomization until death | — |
Countries
Germany
Outcome results
None listed