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A Phase III Trial Comparing Conventional Adjuvant Temozolomide
With Dose-Intensive Temozolomide in Patients with Newly Diagnosed
Glioblastoma
Histopathologically proven diagnosis of glioblastoma multiforme;
Patient must have at least 1 block of tissue available for analysis
of MGMT status; Fresh frozen tumor tissue acquisition is encouraged;
Diagnosis must be made by surgical biopsy or excision; Tumor must
have a supratentorial component; Patient must have recovered from
the effects of surgery, postoperative infection and other complications
before study registration; A diagnostic contrast-enhanced MRI or
CT scan (if MRI is not available) of the brain must be performed
preoperatively and postoperatively prior to the initiation of radiotherapy,
within 28 days prior to study registration; Preoperative and postoperative
scans must be the same type; If CT scans were performed perioperatively,
a CT and an MRI should be performed before randomization; Patients
diagnosed only by stereotactic biopsy do not require the postoperative
scan. However, these patients will only be eligible once review
of the tissue block determines that an adequate sample is available
for molecular analysis; Patients unable to undergo MR imaging because
of noncompatible devices can be enrolled, provided pre- and postoperative
contrast-enhanced CT scans are obtained and are of sufficient quality;
Therapy must begin 5 weeks after surgery; History/physical examination
within 14 days prior to study registration; Neurologic examination
within 14 days prior to study registration; Documentation of steroid
doses within 14 days prior to study registration and stable or
decreasing steroid dose within 5 days prior to registration; Karnofsky
performance status of > 60; Patient must > 18 years of age;
CBC/differential obtained within 14 days prior to study registration,
with adequate bone marrow function as defined as: Absolute neutrophil
count (ANC) > 1500 cells/mm3; Platelets > 100,000 cells/mm3;
Hemoglobin > 10 g/dl. (Note: The use of transfusion or other
intervention to achieve Hgb > 10 g/dl is acceptable); Adequate
renal function, as defined as: BUN < 25 mg/dl within 14 days
prior to study registration; Creatinine < 1.7 mg/dl within 14
days prior to study registration; Adequate hepatic function, as
defined as: Bilirubin < 2.0 mg/dl within 14 days prior to
study registration; ALT < 3 x normal range within 14 days prior
to study registration; AST < 3 x normal range within 14 days
prior to study registration; Patient must sign a study-specific
informed consent prior to study registration; If the patient's
mental status precludes his/her giving informed consent, written
informed consent may be given by the responsible family member;.
For females of childbearing potential, negative serum pregnancy
test within 72 hours prior to starting temozolomide; Women of childbearing
potential and male participants must practice adequate contraception.
Radiation (60 Gy in 2 Gy fractions)
Concurrent daily TMZ (qd x 49 d maximum)
Followed by:
Arm 1 (Standard Arm): TMZ d 1-5 of 28-d cycle; 6 cycles*
Arm 2 (Experimental Arm):TMZ d 1-21 of 28-d cycle; 6 cycles*
* Up to 12 cycles may be given if the patient demonstrates continued
improvement on MRI scan, decreasing corticosteroid requirement,
improvement in performance status or improvement in neurologic
function.
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