PI/II of Temozolomide & Hypofractionated Radiotherapy in Tx of Supratentorial Glioblastoma Multiform
This study is currently recruiting participants.
Verified January 2013 by Stanford University
Sponsor:
Stanford University
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01120639
First received: May 7, 2010
Last updated: January 16, 2013
Last verified: January 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Glioblastoma Cancer of Brain and Nervous System Glioblastoma Multiforme |
Drug: Temozolomide Procedure: Stereotactic Radiosurgery |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I/II Trial of Temozolomide and Hypofractionated Radiotherapy in Treatment of Supratentorial Glioblastoma Multiforme |
Resource links provided by NLM:
Further study details as provided by Stanford University:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
- Determine the progression-free survival rate. [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Determine the short- and long-term adverse effects. [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
- Determine the radiographic response rate. [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
- Determine the overall survival rate. [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
- Perform patterns of failure analysis. [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
- Assess quality of life during treatment. [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 24 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: PTV (Planning Target Volume) less than 60 cm3
Hypofractionated radiotherapy with concurrent temozolomide Dose Levels:
|
Drug: Temozolomide
75 mg/m2/day, oral
Other Names:
Procedure: Stereotactic Radiosurgery
Standard of care
Other Name: Cyberknife surgery
|
|
Experimental: PTV (Planning Target Volume) between 60 and 150 cm3
Hypofractionated radiotherapy with concurrent temozolomide Dose Levels:
|
Drug: Temozolomide
75 mg/m2/day, oral
Other Names:
Procedure: Stereotactic Radiosurgery
Standard of care
Other Name: Cyberknife surgery
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01120639
Contacts
| Contact: Leslie Modlin | (650) 723-8843 | lmodlin@stanford.edu |
Locations
| United States, California | |
| Stanford University School of Medicine | Recruiting |
| Stanford, California, United States, 94305 | |
| Contact: Melody Chung 650-736-0798 mxchung@stanford.edu | |
| Contact: Cancer Clinical Trials Office (650) 498-7061 | |
| Principal Investigator: Scott Soltys | |
| Sub-Investigator: Dr Lawrence Recht | |
| Sub-Investigator: Griffith R. Harsh | |
| Sub-Investigator: Iris Catrice Gibbs | |
| Sub-Investigator: Clara Choi | |
| Sub-Investigator: Steven Daniel Chang | |
Sponsors and Collaborators
Stanford University
Investigators
| Principal Investigator: | Scott Soltys | Stanford University |
More Information
No publications provided
| Responsible Party: | Stanford University |
| ClinicalTrials.gov Identifier: | NCT01120639 History of Changes |
| Other Study ID Numbers: | BRN0012, SU-04202010-5726, 17774 |
| Study First Received: | May 7, 2010 |
| Last Updated: | January 16, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Brain Neoplasms Glioblastoma Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Neoplasms Brain Diseases Central Nervous System Diseases Nervous System Diseases Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Temozolomide Dacarbazine Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013