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

Phase 2

• Conditions: Glioblastoma Multiforme
• Interventions: Radiation: Hypofractionated IMRT; Biological: Granulocyte-macrophage Colony-stimulating Factor; Drug: Temozolomide

• Registration Number: NCT02663440
• Lead Sponsor: Zhejiang Cancer Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-01
• Study Start: 2016-01
• Study First Submitted: 2016-01-18
• Study First Submitted QC: 2016-01-21
• Last Update Submitted: 2016-01-21
• Study First Posted: 2016-01-26
• Last Update Posted: 2016-01-26
• Primary Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 41

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IMRT	Hypofractionated IMRT	Hypofractionated IMRT With Temozolomide and Granulocyte-macrophage Colony-stimulating Factor
IMRT	Granulocyte-macrophage Colony-stimulating Factor	Hypofractionated IMRT With Temozolomide and Granulocyte-macrophage Colony-stimulating Factor
IMRT	Temozolomide	Hypofractionated IMRT With Temozolomide and Granulocyte-macrophage Colony-stimulating Factor

Primary Outcome Measures

Name	Time	Method
PFS	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

Trial Locations

Locations (1)

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China