Clinical Trial Details
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NCT02029573 : Efficacy and Safety of Atorvastatin in Combination With Radiotherapy and Temozolomide in Glioblastoma
PhasePhase 2
AgesMin: 18 Years Max: 70 Years
Inclusion Criteria:

- Histologically proven newly diagnosed Malignant Glioblastoma Multiforme or variants
(gliosarcoma, glioblastoma with oligodendroglial features, giant cell glioblastoma).

- Age ? 18 years.

- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.

- Patients must have an estimated life expectancy of at least 12 weeks.

- No prior chemotherapy or radiotherapy.

- Stable dose of steroid for ? 14 days prior to registration.

- Patients must have adequate bone marrow function (e.g., hemoglobin ?10 g/dl, absolute
granulocyte count ? 1.5 x 109/L, and platelet count ?100 x 109/L.

- Adequate liver function (SGPT, SGOT, and alkaline phosphatase ? 2.5 times upper
limits of normals (ULN) and total bilirubin ?1.5 x ULN), and adequate renal function
(BUN or creatinine ?1.5 X ULN) prior to starting therapy.

- Paraffin embedded tumour sample available for study.

- Patient consent must be obtained according to local Institutional requirements. The
patient must sign the consent form prior to registration.

- Protocol treatment is to begin within 10 working days of patient registration.

Exclusion Criteria:

- Pregnant or lactating women; men and women of childbearing potential must agree to
practice an effective method of birth control. Women of childbearing potential must
have a negative pregnancy test performed within 14 days prior to registration.

- Concurrent treatment with other experimental drugs or anticancer therapy.

- Patients with a history of other malignancies, except: adequately treated
non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other
solid tumours curatively treated with no evidence of disease for > 5 years.

- Prior radiotherapy or systemic cytotoxic chemotherapy .

- Severe, active co-morbidity, defined as follows: Acute bacterial or fungal infection
requiring intravenous antibiotics at the time of registration, Chronic obstructive
pulmonary disease exacerbation or other respiratory illness requiring hospitalization
or oxygen, Hepatic insufficiency or Active liver disease resulting in clinical
jaundice and/or coagulation defects, Acquired immune deficiency syndrome (AIDS) ,
Significant neurologic or psychiatric disorder which would impair the ability to
obtain informed consent, Active uncontrolled or serious infection, active peptic
ulcer disease, Any medical condition which could interfere with oral medication
intake (e.g., frequent vomiting, partial bowel obstruction), Myocardial infarction
within 6 months prior to registration, Congestive heart failure, unstable angina,
active cardiomyopathy, cardiac arrhythmia, Skeletal muscle disease and other related
reticule-endothelial diseases.

- Patients with known hypersensitivity to the study drugs or their components.
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