NCT02092038

Preoperative Chemoradiation for Glioblastoma

Phase I Pilot Study of Preoperative Chemoradiation for Glioblastoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Tampa General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Prior to any definitive treatment and after enrollment, the patient will undergo stereotactic biopsy of the lesion to confirm the histology of the lesion and to determine methylated methylguanine methyltransferase (MGMT) status. Standard image-guided stereotactic technique will be used. Patients will be treated with conformal radiation therapy. Temozolomide will be given from the day prior to radiation therapy through the last day of radiation therapy. 4-6 weeks after radiation therapy the patient will undergo craniotomy and maximal safe resection. Temozolomide will continue beginning 4 weeks after surgery. Imaging: MRI within 2 weeks prior to the start of the protocol. MRI at 4 weeks after chemoradiation therapy and prior to surgery. MRI within 48 hours after surgery. MRI after every 2 cycles of chemotherapy and then every 2 months until progression, up to 2 years.

Conditions

• Glioblastoma

Interventions

Type	Name	Description
DRUG	Temozolomide	Neoadjuvant treatment with concurrent temozolomide and radiation therapy, followed by surgery and then further temozolomide.
RADIATION	partial brain irradiation	Neoadjuvant treatment with concurrent temozolomide and radiation therapy, followed by surgery and then further temozolomide.
PROCEDURE	stereotactic biopsy of brain tumor	will be assessed for tumor type and tumor markers
PROCEDURE	craniotomy and tumor resection	maximal safe resection

Timeline

• Start date: 2014-11-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2014-03-19
• Last updated: 2015-11-10

Locations

1 site across 1 country: United States