Clinical Trials at Englewood Hospital: Oncology
EHMC IRB Study #: E-13-480
Dr. Kevin Yao
National Cancer Institute - ECOG
E3F05: Phase III Study of Radiation Therapy with or without Temozolomide for Symptomatic or Progressive Low-Grade Gliomas
Patients must be 18 years or older with tumors located in the cerebrum of the brain with a pathological diagnosis of astrocytoma grade 2, oligodendroglioma grade 2,
or oligoastrocytoma grade 2 . The patient must currently have at least one of the following: (1.) Tumor progression or (2.) uncontrolled seizures despite the use of anticonvulsives;
headaches; neurologic symptoms and cognitive symptoms or deficits or (3.) Age 40 years and older.
To participate in the study, the patient must have paraffin-embedded
tumor tissue available to be sent to a central pathology facility for study review.
To determine whether the addition of Temozolomide (chemotherapy) to fractionated
(dividing radiation into multiple smaller doses) radiotherapy improves the progression
free survival (PFS) as well as the overall survival (OS) of patients with low grade gliomas requiring treatment.
These treatment regimens will also be evaluated for whether they improve or maintain cognition and quality of life (QOL) of the patient.
Summary of procedures:
All patients will be randomized 1:1 into either Arm A or Arm B. Subjects in Arm A will receive standard therapy of radiation for 5 ½ weeks (Monday - Friday no weekends).
Arm B patients will receive standard radiation therapy PLUS daily oral dosing of temozolomide. Temozolomide will be taken daily until the radiation is completed. If the radiation
lasts longer than 42 days, the patient will stop taking the temozolomide until 28 days after the radiation is completed.
The patient will then receive cycles of temozolomide alone consisting of 5 days of daily oral dosing every 28 days. Temozolomide may be continued for up to 12 cycles as long as it is tolerated and there is no disease progression.
Regardless of treatment arm, patients will undergo physical examination and MRI every 12 weeks following the completion of treatment for up to 15 years or until the tumor grows.