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

University of Chinese Academy Sciences

Status and phase: Unknown; Phase 2

Conditions: Glioblastoma Multiforme

Treatments: Drug: Temozolomide; Biological: Granulocyte-macrophage Colony-stimulating Factor; Radiation: Hypofractionated IMRT

Study type: Interventional

Funder types: Other

Identifiers

NCT02663440

ZJZLYY-HN-2016-01

Details and patient eligibility

About

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.

Enrollment: 41 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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41 participants in 1 patient group

IMRT

Experimental group

Description:

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

Treatment:

Drug: Temozolomide

Biological: Granulocyte-macrophage Colony-stimulating Factor

Radiation: Hypofractionated IMRT