Preoperative Chemoradiation for Glioblastoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2015-07-31

Brief Summary

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

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Detailed Description

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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

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Glioblastoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Preoperative chemoradiation

Stereotactic biopsy of brain tumor, then partial brain irradiation and temozolomide, followed by craniotomy and tumor resection, followed by temozolomide

Group Type EXPERIMENTAL

Temozolomide

Intervention Type DRUG

Neoadjuvant treatment with concurrent temozolomide and radiation therapy, followed by surgery and then further temozolomide.

partial brain irradiation

Intervention Type RADIATION

Neoadjuvant treatment with concurrent temozolomide and radiation therapy, followed by surgery and then further temozolomide.

stereotactic biopsy of brain tumor

Intervention Type PROCEDURE

will be assessed for tumor type and tumor markers

craniotomy and tumor resection

Intervention Type PROCEDURE

maximal safe resection

Interventions

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Temozolomide

Neoadjuvant treatment with concurrent temozolomide and radiation therapy, followed by surgery and then further temozolomide.

Intervention Type DRUG

partial brain irradiation

Neoadjuvant treatment with concurrent temozolomide and radiation therapy, followed by surgery and then further temozolomide.

Intervention Type RADIATION

stereotactic biopsy of brain tumor

will be assessed for tumor type and tumor markers

Intervention Type PROCEDURE

craniotomy and tumor resection

maximal safe resection

Intervention Type PROCEDURE

Other Intervention Names

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Temodar

Eligibility Criteria

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Inclusion Criteria

* 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