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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02663440

Enrollment

Registered

2016-01-26

Start date

2016-01-31

Completion date

Unknown

Last updated

2016-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioblastoma Multiforme

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.

Interventions

RADIATIONHypofractionated IMRT

Hypofractionated IMRT

BIOLOGICALGranulocyte-macrophage Colony-stimulating Factor

Granulocyte-macrophage Colony-stimulating Factor

DRUGTemozolomide

Temozolomide

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame
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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026