Clinical Trial Details
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[Information provided by:, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02805179 : A Study of High-Dose Chemoradiation Using Biologically-Based Target Volume Definition in Patients With Glioblastoma
PhasePhase 2
AgesMin: 18 Years Max: N/A
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

- 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.
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