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A Phase I/II Trial of Temozolomide and Hypofractionated Radiotherapy in Treatment of Supratentorial Glioblastoma Multiforme


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Glioblastoma, Cancer of Brain and Nervous System, Glioblastoma Multiforme

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Trial Information

A Phase I/II Trial of Temozolomide and Hypofractionated Radiotherapy in Treatment of Supratentorial Glioblastoma Multiforme


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the maximum tolerated dose (MTD) of hypofractionated radiotherapy given in 5 fractions with temozolomide for the treatment of glioblastoma multiforme

Outcome Time Frame:

Duration of study

Safety Issue:

Yes

Principal Investigator

Scott Soltys

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University

Authority:

United States: Institutional Review Board

Study ID:

BRN0012

NCT ID:

NCT01120639

Start Date:

April 2010

Completion Date:

May 2014

Related Keywords:

  • Glioblastoma
  • Cancer of Brain and Nervous System
  • Glioblastoma Multiforme
  • Brain Neoplasms
  • Glioblastoma

Name

Location

Stanford University School of MedicineStanford, California  94305-5317