Trial of Hypofractionated Intensity Modulated Radiation Therapy With Temozolomide and Granulocyte-macrophage Colony-stimulating Factor for Patients With Newly Diagnosed Glioblastoma Multiforme

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

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Brief Summary

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Phase II Trial of Hypofractionated Intensity Modulated Radiation Therapy(IMRT) With Temozolomide and Granulocyte-macrophage Colony-stimulating Factor(GM-CSF) for Patients With Newly Diagnosed Glioblastoma Multiforme.

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Detailed Description

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Conditions

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Glioblastoma Multiforme

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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IMRT

Hypofractionated IMRT With Temozolomide and Granulocyte-macrophage Colony-stimulating Factor

Group Type EXPERIMENTAL

Hypofractionated IMRT

Intervention Type RADIATION

Hypofractionated IMRT

Granulocyte-macrophage Colony-stimulating Factor

Intervention Type BIOLOGICAL

Granulocyte-macrophage Colony-stimulating Factor

Temozolomide

Intervention Type DRUG

Temozolomide

Interventions

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Hypofractionated IMRT

Intervention Type RADIATION

Granulocyte-macrophage Colony-stimulating Factor

Intervention Type BIOLOGICAL

Temozolomide

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Newly diagnosed and pathologically confirmed glioblastoma multiforme without an enhanced lesion beside the cerebrospinal fluid space on baseline magnetic resonance imaging
* Karnofsky performance status more than 60
* Normal liver, kidney, and bone marrow function.

Exclusion Criteria

* Previous allergies to granulocyte macrophage colony stimulating factor
* Receiving radiotherapy
* Receiving other investigational agents
* Had uncontrolled intercurrent illnesses.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No