cropped color_logo_with_background.png

Clinical Trial Finder

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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT01120639
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Stanford University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Scott Gerard Soltys, MD
Principal Investigator Affiliation Stanford University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma, Cancer of Brain and Nervous System, Glioblastoma Multiforme
Additional Details

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.

Arms & Interventions

Arms

Experimental: Stereotactic Radiosurgery (25 Gray x 5 fractions)+Temozolomide

Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) < 60 cm³ vs 60 to 150 cm³.

Experimental: Stereotactic Radiosurgery (30 Gray x 5 fractions)+Temozolomide

Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) < 60 cm³ vs 60 to 150 cm³.

Experimental: Stereotactic Radiosurgery (35 Gray x 5 fractions)+Temozolomide

Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) < 60 cm³ vs 60 to 150 cm³.

Experimental: Stereotactic Radiosurgery (40 Gray x 5 fractions)+Temozolomide

Hypofractionated stereotactic radiosurgery with concurrent temozolomide, stratified by Planning Target Volume (PTV) < 60 cm³ vs 60 to 150 cm³.

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)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Stanford University School of Medicine, Stanford, California

Status

Address

Stanford University School of Medicine

Stanford, California, 94305

Powered By