NCT01120639

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

Primary Objective: To determine the maximum tolerated dose (MTD), based on acute CNS toxicity at 30 days, of hypofractionated radiotherapy given in 5 fractions with temozolomide for the treatment of glioblastoma multiforme. Secondary Objectives: 1. Assess the short- and long-term adverse effects. 2. Determine the radiographic response rate. 3. Determine the overall survival rate. 4. Assess quality of life during treatment 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.

Conditions

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

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2010-04-01
• Primary completion: 2016-11-01
• Completion: 2020-11-15
• First posted: 2010-05-11
• Last updated: 2021-08-06
• Results posted: 2019-07-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study