Clinical Trial Details
Braintumor Website

[Information provided by:, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT00626990 : Radiation Therapy With or Without Temozolomide in Treating Patients With Anaplastic Glioma
PhasePhase 3
AgesMin: 18 Years Max: N/A

- Histologically confirmed diagnosis of 1 of the following:

- Anaplastic oligodendroglioma

- Anaplastic oligoastrocytoma

- Anaplastic astrocytoma

- Newly diagnosed disease

- Prior surgery for a low grade tumor is allowed, provided histological confirmation of
an anaplastic tumor is present at the time of progression

- Absence of combined 1p/19q loss

- Tumor material available for central 1p/19q assessment, central O6-methylguanine-DNA
methyltransferase promoter methylation status assessment, isocitrate dehydrogenase
mutation analysis, and central pathology review

- Patients must be on a stable or decreasing dose of steroids for at least two weeks
prior to randomization


- WHO performance status 0-2

- ANC ? 1.5 x 10^9 cells/L

- Platelet count ? 100 x 10^9 cells/L

- Bilirubin < 1.5 x upper limit of normal (ULN)

- Alkaline phosphatase < 2.5 x ULN

- AST and ALT < 2.5 x ULN

- Serum creatinine < 1.5 x ULN

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No known HIV infection or chronic hepatitis B or hepatitis C infection

- No other serious medical condition that would interfere with follow-up

- No medical condition that could interfere with oral medication intake (e.g., frequent
vomiting or partial bowel obstruction)

- No other prior malignancies except for any malignancy which was treated with curative
intent more than 5 years prior to registration and adequately controlled limited
basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma
in situ of the cervix

- No prior or concurrent malignancies at other sites except for surgically cured
carcinoma in situ of the cervix or nonmelanoma skin cancer

- No psychological, familial, sociological, or geographical condition that would
potentially hamper compliance with the study protocol and follow-up schedule


- See Disease Characteristics

- No prior chemotherapy, including carmustine-containing wafers (Gliadel®)

- No prior radiotherapy to the brain

- No concurrent growth factors unless vital for the patient

- No other concurrent investigational treatment

- No other concurrent anticancer agents
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