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A Phase II Study of Temozolomide-Based Chemoradiotherapy Regimen
for High Risk Low-Grade Gliomas
Histological proof of a unifocal or multifocal supratentorial
WHO Grade II astrocytoma (diffuse fibrillary, protoplasmic, or
gemistocytic), oligodendroglioma, or oligoastrocytoma confirmed
by central pathology review prior to registration; Patients must
have at least 3 of the following risk factors: Age > 40 years;
largest preoperative diameter of tumor > 6 cm; Tumor crosses
midline; Tumor subtype of astrocytoma (astrocytoma dominant); Preoperative
Neurological Function Status (NFS)> 1. Zubrod Performance Status
0-2; Mandatory evaluations; Required laboratory tests within 14
days prior to registration: CBC with differential, ANC > 1500/mm3;
Platelet count > 100 x 109/l; Biochemistries including sodium,
potassium, Serum creatinine < 1.5 mg/dl; Total bilirubin < 1.5
mg/dL: SGOT (AST) or SGPT and alkaline phosphate < 2 x institutional
normal range; History and physical exam (including neurologic exam)
with documentation of baseline signs, symptoms and medications,
including steroids and anticonvulsants within 14 days prior to
registration; Pre-operative and post-operative MRIs with and without
contrast obtained within 4 weeks of date of surgery; MRI must include
T1 weighted images with and without contrast and T2 weighted images;.
Patients who undergo biopsy only do not need a post-op MRI; Pre-op
or post-op CT scans are not acceptable (see Section 11.1 for details);
Chest X-ray within 12 weeks prior to registration; Negative serum
pregnancy test for women of childbearing potential within 5 days
prior to registration; Patients must sign study-specific informed
consent form prior to study entry.
Daily temozolomide plus concurrent radiotherapy (54 Gy/30 fractions/6
weeks) followed by temozolomide x 12 cycles.
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