None listed
Conditions
Brief summary
A randomized study to demonstrate a difference in progression-free survival (PFS) for primary treatment with temozolomide in order to assess: whether PFS and OS can be prolonged by primary chemotherapy with temozolomide, whether the incidence of late toxicity can be decreased by using primary chemotherapy, the toxicity profile of the two treatments and the quality of life of the patients The impact of 1p deletions in low-grade gliomas: prognostic effect of tumors with deletion on PFS overall and by treatment group. Benefit for patients with LGGs and deletions treated with TMZ compared to radiotherapy alone with respect to survival. Interaction between treatment and cytogenetic features.
Interventions
Arm B: Temozolomide administered orally 75 mg/m2 daily x 21 days (one cycle), q 28 days until progression or for max. 12 cycles (experimental arm)
Sponsors
European Organisation for Research and Tretment of Cancer (EORTC)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to -2147483648 No limit
Healthy volunteers
No
Inclusion criteria
At registration: - Histologically proven low grade diffuse glioma astrocytoma WHO grade II (gemistocytic, fibrillary and protoplasmatic) oligoastrocytoma WHO grade II oligodendroglioma WHO II - Supratentorial location only - WHO performance status = 2 - Not candidate for treatment exclusively by surgery - RTOG neurological function 0-3 - Results of genetic testing (1p) available - Adequate haematological, renal and hepatic function - Histopathologic slides available for central pathology review - Tumour material (paraffin-embedded) and blood available for molecular testing - Written informed consent At randomisation: Same as above PLUS - Requiring treatment as demonstrated by at least one of the following criteria (1-4): 1. Age = 40 years 2. Radiologically proven progressive lesion 3. New or worsening neurological symptoms other than seizures only (focal deficits, signs of raised intracranial pressure, mental deficits) 4. Intractable seizures, defined as having both: persistent seizures interfering with everyday life activities other than driving a car AND failed three lines of anti-epileptic drug regimen, including at least one combination regimen - RTOG Neurological Function 0-3 - Not candidate for treatment exclusively with surgery - Must have recovered from any prior surgery - 1p test result available (for stratification: 1p deleted versus 1p normal versus undeterminable) - Baseline quality of life questionnaires (QLQ-C30 + BN20) completed - Prepared to use effective contraception for the duration of the treatment and for 6 months after(applies to all patients with reproductive potential - male and female)
Exclusion criteria
- Previous irradiation of the brain - Previous chemotherapy - Previous or concurrent malignancies at other sites with the exception of surgically cured carcinoma in-situ of the cervix and non-melanoma skin cancer - Known HIV infection, chronic hepatitis B or hepatitis C infection - Any other serious medical contraindication as per the judgment of the treating physician - Any medical condition which could interfere with oral medication intake (e.g. frequent vomiting, partial bowel obstruction) - Female pregnant or lactating - Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule as discussed with the patient before randomization
Outcome results
None listed