Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy,
such as temozolomide, work in different ways to stop the growth of tumor cells, either by
killing the cells or by stopping them from dividing. It is not yet known whether giving
radiation with concomitant and adjuvant temozolomide versus radiation with adjuvant PCV is
more effective in treating anaplastic glioma or low grade glioma.
This study will be a randomized phase III for patients with newly diagnosed co-deleted 1p/19q
anaplastic glioma or high risk low grade glioma. The trial will only enroll patients with
1p/19q co-deletion. This study includes two arms as described in the "Arms" section. A
dynamic allocation procedure will be used to allocate an equal number of patients to
different arms (Arms A:B = 1:1). This procedure will balance the marginal distributions of
the stratification factors among arms. The stratification factors that will be used are
cooperative groups (EORTC vs. all North American groups), age ( 50 vs. > 50), performance
score (ECOG 0-1 vs. 2), and tumor grade (anaplastic glioma vs. low grade glioma).
The primary goal is to determine whether patients who receive radiotherapy with concomitant
temozolomide (TMZ) followed by adjuvant temozolomide (RT + TMZ --> TMZ) (Arm B) have a
marginally better progression free survival (PFS) as compared with patients who receive
radiotherapy followed by PCV chemotherapy (RT --> PCV)(Arm A).
Time to Progression - To determine whether patients who receive (RT + TMZ --> TMZ) have
a significantly longer time to progression (clinical or radiographic progression) as
compared with patients who receive radiotherapy followed by adjuvant PCV chemotherapy
(RT --> PCV).
Correlation between exploratory biomarkers and survival - To determine whether there is
a difference in survival based on t(1;19)(q10, p10) translocation status and MGMT
promoter hypermethylation status.
Descriptive Comparisons of Additional Secondary Endpoints - To perform descriptive
comparisons of additional secondary outcome endpoints, including overall survival,
objective tumor response, prognostic factor analysis and quality of life.
Toxicity - To determine the toxicity of the treatment in each arm and perform
Neurocognitive and Quality of Life (QOL) Effects - To determine the neurocognitive and
QOL effects in patients treated on this protocol and correlate these results with
Banking of Biospecimens and Neuroimaging Studies - To store blood products (i.e.,
plasma, DNA and buffy coat), tumor tissue and MRI/CT images for future scientific
After completion of study treatment, patients are followed every 12 weeks for 1 year, then
every 4 months for 2 years and then every 6 months until progressive disease or until the end
of study participation.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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