Overview

This trial is active, not recruiting.

Conditions glioblastoma, cancer of brain and nervous system, glioblastoma multiforme
Treatments temozolomide, stereotactic radiosurgery
Phase phase 1/phase 2
Sponsor Stanford University
Start date April 2010
End date November 2016
Trial size 30 participants
Trial identifier NCT01120639, 17774, BRN0012, SU-04202010-5726

Summary

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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Hypofractionated stereotactic radiosurgery with concurrent temozolomide Dose Levels: 25 Gy in 5 fractions 30 Gy in 5 fractions 35 Gy in 5 fractions 40 Gy in 5 fractions
temozolomide Temodar
75 mg/m2/day, oral
stereotactic radiosurgery Cyberknife surgery
Standard of care
(Experimental)
Hypofractionated stereotactic radiosurgery with concurrent temozolomide Dose Levels: 25 Gy in 5 fractions 30 Gy in 5 fractions 35 Gy in 5 fractions 40 Gy in 5 fractions
temozolomide Temodar
75 mg/m2/day, oral
stereotactic radiosurgery Cyberknife surgery
Standard of care

Primary Outcomes

Measure
Determine the maximum tolerated dose (MTD) of hypofractionated radiotherapy given in 5 fractions with temozolomide for the treatment of glioblastoma multiforme
time frame: Duration of study

Secondary Outcomes

Measure
Determine the progression-free survival rate.
time frame: Duration of study
Determine the short- and long-term adverse effects.
time frame: Duration of study
Determine the radiographic response rate.
time frame: Duration of study
Determine the overall survival rate.
time frame: Duration of study
Perform patterns of failure analysis.
time frame: Duration of study
Assess quality of life during treatment.
time frame: Duration of study

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Phase I/II Trial of Temozolomide and Hypofractionated Radiotherapy in Treatment of Supratentorial Glioblastoma Multiforme
Principal investigator Scott Soltys
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2017.
Information provided to ClinicalTrials.gov by Stanford University.