NCT02663440

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 26, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Last Updated

January 26, 2016

Status Verified

January 1, 2016

Enrollment Period

1.9 years

First QC Date

January 18, 2016

Last Update Submit

January 21, 2016

Conditions

Glioblastoma Multiforme

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

IMRT

EXPERIMENTAL

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

Radiation: Hypofractionated IMRTBiological: Granulocyte-macrophage Colony-stimulating FactorDrug: Temozolomide

Interventions

Hypofractionated IMRTRADIATION

Hypofractionated IMRT

IMRT
Granulocyte-macrophage Colony-stimulating FactorBIOLOGICAL

Granulocyte-macrophage Colony-stimulating Factor

IMRT
TemozolomideDRUG

Temozolomide

IMRT

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

Related Publications (1)

  • Cao C, Wang L, Jiang F, Jin Q, Jin T, Huang S, Hu Q, Chen Y, Piao Y, Hua Y, Feng X, Zhou Y, Chen X. Granulocyte-macrophage colony-stimulating factor for newly diagnosed glioblastoma. Neoplasia. 2025 May;63:101156. doi: 10.1016/j.neo.2025.101156. Epub 2025 Mar 15.

    PMID: 40090128DERIVED

MeSH Terms

Conditions

Glioblastoma

Interventions

Granulocyte-Macrophage Colony-Stimulating FactorTemozolomide

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsDacarbazineTriazenesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2016

First Posted

January 26, 2016

Study Start

January 1, 2016

Primary Completion

December 1, 2017

Last Updated

January 26, 2016

Record last verified: 2016-01

Locations

CN(1)