a study of high-dose chemoradiation using biologically-based target volume definition in patients with glioblastoma

Conditions: Glioma

Summary: this is a study to determine the safety and effectiveness of high-dose radiation therapy (rt) with concurrent temozolomide in patients with newly diagnosed glioblastoma.

after analysis demonstrated the improved prognostic value of identifying both hypercellular tumor (tvhcv) based on high b-value diffusion-weighted magnetic resonance imaging (dw-mri) and hyperperfused tumor (tvcbv) based on dynamic contrast-enhanced mri (dce-mri), the study was amended and later-enrolled patients boosted to both tvhcv and tvcbv.

Eligibility criteria:
inclusion criteria: * newly diagnosed histologically-confirmed supratentorial world health organization (who) grade iv gliomas including glioblastoma multiforme and gliosarcoma * age 18 or older * karnofsky performance status (a measure to quantify general well being and activities of daily life; scale ranges from 0 to 100 where 100 is perfect health) of greater than or equal to 70 * life expectancy of at least 12 weeks * adequate bone marrow reserve (hemoglobin greater than or equal to 10, absolute neutrophil count greater than or equal to 1500, platelets greater than or equal to 100,000); acceptable liver function (total bilirubin less than or equal to 2.0 mg/dl, alt (alanine aminotransferase)/ast (aspartate aminotransferase) less than or equal to 5 times the normal range); acceptable renal function (serum creatinine less than or equal to 2.0 mg/dl). eligibility level for hemoglobin may be reached by transfusion. * maximal contiguous volume of tumor based on high b-value diffusion mri \< 1/3 volume of brain * patients must be registered within 6 weeks of most recent resection. * patients must have signed a study-specific informed consent. exclusion criteria: * recurrent glioma, or tumor involving the brainstem or cerebellum. prior low-grade glioma without prior rt, now with malignant progression are eligible. * prior use of gliadel wafers or any other intratumoral or intracavitary treatment is not permitted. prior chemotherapy for a different cancer is allowable, except for temozolomide or bevacizumab. * evidence of cerebrospinal fluid dissemination (positive cerebrospinal fluid cytology for malignancy or mri findings consistent with csf dissemination) * evidence of severe concurrent disease requiring treatment * prior invasive malignancy (except non-melanoma skin cancer) unless disease-free for a minimum of 3 years (for example, carcinoma in situ of breast, oral cavity or cervix are all permissible) * patients unable to undergo magnetic resonance imaging exams (mri) (i.e. patients with non-compatible devices such as cardiac pacemakers, other implanted electronic devices, metallic prostheses, or ferromagnetic prostheses (e.g. pins in artificial joints and surgical pins/clips) or unable to receive gadolinium for mri, as per the standard um department of radiology mri screening criteria) * patients treated with previous cranial or head/neck radiotherapy leading to radiation field overlap * females of child-bearing potential must have a negative pregnancy test within 14 days prior to registration. patients with reproductive potential must agree to use an effective contraceptive method during treatment.