Preoperative Chemoradiation for Glioblastoma

Completed · Phase 1

Conditions studied: Glioblastoma

In brief

Trial to determine the safety of neoadjuvant treatment with concurrent temozolomide and radiation therapy, followed by surgery and then further temozolomide.

Key facts

Study ID

NCT02092038

Run by

Tampa General Hospital

People needed

1

Starts

2014-11-01

Expected to finish

2015-07-01

Last updated by the study team

2015-11-10

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• MRI lesions of the brain that have a high probability of being glioblastoma in a potentially resectable location in the brain (the primary study population)
• WHO performance status 0-2 (to allow comparison to historical controls)
• Adequate hematological parameters: (for safety because of neutropenia from the temozolomide)
• Consent can be obtained from the patient, and if the patient cannot give consent then from the medical power of attorney and if one is not assigned, then the nearest relative (required to obtain consent)
• Able to have MRI scans (secondary endpoint is MRI scan characteristics)
• Willing to have radiation treatment at a participating center (homogeneity of treatment parameters)
• Ages 18-80

You may not qualify if…

• Unresectable tumor
• Absolute neutrophil count (ANC) less than 1,200/μL
• Hemoglobin less than 9.0g/dL
• Platelet count less than 100,000/μL

Where it is running

• Tampa General Hospital — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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