P1/2 of Temozolomide and Hypofractionated Radiotherapy in Tx of Supratentorial Glioblastoma Multiform



Status:Active, not recruiting
Conditions:Cancer, Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:April 2010
End Date:November 2020

Use our guide to learn which trials are right for you!

A Phase 1/2 Trial of Temozolomide and Hypofractionated Radiotherapy in Treatment of Supratentorial Glioblastoma Multiforme

The purpose of this study is to investigate the safety and effectiveness of a combination
treatment for glioblastoma multiforme utilizing radiotherapy with the FDA approved
chemotherapy drug temozolomide

To determine the maximum tolerated dose (MTD) of hypofractionated (5 fractions) radiotherapy
with temozolomide for the treatment of glioblastoma multiforme, patients will be evaluated by
a multi-disciplinary team composed of radiation oncologists, neurosurgeons, and
neuro-oncologists to assess for their eligibility. Patient's oncologic history, presenting
symptoms, physical examination, pathology, and imaging studies will be reviewed. Patients
will be evaluated for surgical candidacy and resectability. Patients who are surgical
candidates will undergo a surgical resection prior to radiotherapy. Patients whose tumors are
unresectable or are not good surgical candidates will undergo a biopsy for tissue diagnosis.
Radiation will be delivered in five fractions.

Inclusion Criteria:

- Histopathologically confirmed newly diagnosed glioblastoma multiforme. Diagnosis must
be made by surgical biopsy or excision

- The tumor must be supratentorial in location

- The planning target volume (tumor plus margin) must measure ≤ 150 cm^3 in volume

- Age ≥ 18 years

- Life expectancy of at least 12 weeks

- Patient must have adequate organ function to tolerate temozolomide (details in the
protocol)

Exclusion Criteria:

- Patients who have previously been treated with brain irradiation to the region that
would result in overlap of the radiation fields

- Tumor foci detected below the tentorium

- Multifocal disease or leptomeningeal spread

- Prior allergic reaction to the study drugs involved in this protocol

- Patients with pacemaker will be allowed to undergo CT instead of MRI

- Pediatric patients (age < 18), pregnant women, and nursing patients will be excluded
We found this trial at
1
site
291 Campus Dr
Stanford, California 94305
(650) 725-3900
Stanford University School of Medicine Vast in both its physical scale and its impact on...
?
mi
from
Stanford, CA
Click here to add this to my saved trials