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

Zhejiang Cancer Hospital41 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Glioblastoma Multiforme

Interventions

Hypofractionated IMRTRADIATION

Hypofractionated IMRT

Granulocyte-macrophage Colony-stimulating FactorBIOLOGICAL

Granulocyte-macrophage Colony-stimulating Factor

TemozolomideDRUG

Temozolomide

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

RECRUITING

Outcomes

Primary Outcomes

PFS

Time frame: From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

Data from ClinicalTrials.gov

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