Glioblastoma
Conditions
Keywords
Glioblastoma multiforme, Brain tumour
Brief summary
The purpose of the study is to determine the efficacy of gefitinib (IressaTM) in combination with radiotherapy on patients with glioblastoma multiforme.
Interventions
DRUGGefitinib
Sponsors
AstraZeneca
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed informed consent * histologically-or cytologically-confirmed glioblastoma multiforme * age 18 years or older
Exclusion criteria
* Have had prior radiation therapy, immunotherapy, gene therapy and/or chemotherapy for the glioblastoma * co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ * known severe hypersensitivity to ZD1839 or any of the excipients of this product.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective tumour response at 6 months after the end of combination treatment by computerized tomography scan or magnetic resonance imaging of the brain according to Macdonald criteria. | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate at 6 months after the combination treatment, clinical or radiological progression-free-survival, overall survival and safety of ZD1839 in combination with radiotherapy. | — |
Countries
Sweden
Outcome results
None listed