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Spots Global Cancer Trial Database for Preoperative Chemoradiation for Glioblastoma

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We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Preoperative Chemoradiation for Glioblastoma

Official Title: Phase I Pilot Study of Preoperative Chemoradiation for Glioblastoma

Study ID: NCT02092038

Conditions

Glioblastoma

Study Description

Brief 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Tampa General Hospital, Tampa, Florida, United States

Contact Details

Name: Lawrence Berk, MD, PhD

Affiliation: Tampa General Hospital

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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