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Phase 1-2 of Temozolomide and Hypofractionated Radiotherapy in Tx of Supratentorial Glioblastoma Multiform

NCT01120639 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-08-06

Study results available
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Summary

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

Conditions

Interventions

DRUG

Temozolomide

75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.

PROCEDURE

Stereotactic Radiosurgery (SRS)

Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)

Sponsors & Collaborators

Principal Investigators

  • Scott Gerard Soltys, MD · Stanford University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2016-11-30
Completion
2020-11-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01120639 on ClinicalTrials.gov