Primary chemotherapy with temozolomide vs. radiotherapy in patients with low grade gliomas after stratification for genetic 1p loss: a phase III study
- Conditions
- Histologically proven low-grade glioma ? Astrocytoma WHO grade II (gemistocytic, fibrillary and protoplasmatic) ? Oligoastrocytoma WHO grade II ? Oligodendroglioma WHO grade IIMedDRA version: 7.1Level: LLTClassification code 10025783
- Registration Number
- EUCTR2004-002714-11-DK
- Lead Sponsor
- European Organisation for Research and Treatment of Cancer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 699
At the time of registration
•Histologically proven low-grade glioma
•Astrocytoma WHO grade II (gemistocytic, fibrillary and protoplasmatic)
•Oligoastrocytoma WHO grade II
•Oligodendroglioma WHO grade II
•Supratentorial tumor location only
•WHO performance status <=2
•Age = 18 years
•No previous chemotherapy or radiotherapy for brain tumor
•Absence of known HIV infection, chronic hepatitis B or hepatitis C infection
•Absence of any medical condition, which could interfere with oral medication intake (e.g., frequent vomiting, partial bowel obstruction)
•Availability of histopathologic slides for central pathology review (see chapter 6.1.1, criteria of evaluation”; and chapter 13 pathology”)
•Availability of tumor material (paraffin-embedded) and blood for molecular testing*
•Before patient registration, written informed consent for the randomization and for the collection, transfer and analysis of the pathological material, molecular biology testing (1p testing) must be given according ICH GCP, and any applicable local regulations
•For those participating to the translational research, before patient registration, written informed consent for the collection, transfer and analysis of the material for translational research must be given according ICH GCP, and any applicable local regulations
* Patients having had previous 1p testing in a different laboratory than the one specified for this study, will need repeated testing in the central reference laboratory.
At the time of randomization
•Histologically proven low-grade glioma **
** (based on the latest performed histology, if no repeat biopsy has been performed, based on initial histology)
•Astrocytoma WHO grade II (gemistocytic, fibrillary and protoplasmatic)
•Oligoastrocytoma WHO grade II
•Oligodendroglioma WHO grade II;
•Supratentorial tumor location only
•Not candidate for treatment exclusively by surgery
•Requiring treatment as demonstrated by at least one of the following criteria:
•Age = 40 years
•Radiologically proven progressive lesion
•New or worsening neurological symptoms other than seizures only (focal deficits, signs of raised intracranial pressure, mental deficits)
•Intractable seizures defined as:
Suffering from persistent seizures, defined as having both:
•persistent seizures interfering with every day life activities other than driving a car
AND
•failed three lines of anti-epileptic drug regimen, including at least one combination regimen
•WHO performance status <=2
•RTOG Neurological Function 0-3
•1p testing performed (for stratification: 1p deleted versus 1p normal versus undeterminable)
•No previous irradiation to the brain
•No prior chemotherapy
•Patients must have recovered from prior surgery, if applicable
•Adequate hematological, renal and hepatic function according to all of the following laboratory values (to be performed within 14 days, inclusive, prior to randomization):
•Absolute neutrophil count >= 1.5 x109/l
•Platelets >=100x109/l
•Serum creatinine =1.5 times upper limit of laboratory normal
•Total serum bilirubin = 1.5 times upper limit of laboratory normal
•ASAT(AST) or ALAT(ALT) = 2.5 times upper limit of laboratory normal
•Alkaline phosphatase of = 2.5 times upper limit of laboratory normal
•Absence of known HIV infection, chronic hepatitis B or hepatitis C infection
•Absence of any other serious medical condition according to the m
See above
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method