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Status unknownNCT02663440Updated Jan 26, 2016

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

A Phase 2 interventional study of Hypofractionated IMRT and Granulocyte-macrophage Colony-stimulating Factor in Glioblastoma Multiforme, sponsored by Zhejiang Cancer Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-01-26.

Sponsored by Zhejiang Cancer Hospital · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
41
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Glioblastoma Multiforme

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03

In context

Glioblastoma

1,920 studies on the registry are indexed under Glioblastoma; 450 are open to participants now.

This study's planned enrollment of 41 is above the median of 36 across 1,618 interventional studies indexed under Glioblastoma.

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Lead sponsor

Zhejiang Cancer Hospital is the lead sponsor of 271 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Previous allergies to granulocyte macrophage colony stimulating factor
  • Receiving radiotherapy
  • Receiving other investigational agents
  • Had uncontrolled intercurrent illnesses.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
41 participants (estimated)

Study arms

  • Experimental
    IMRT

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

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

Interventions

  • RadiationHypofractionated IMRT

    Hypofractionated IMRT

  • BiologicalGranulocyte-macrophage Colony-stimulating Factor

    Granulocyte-macrophage Colony-stimulating Factor

  • DrugTemozolomide

    Temozolomide

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

1 of 1 sites recruiting
  • Zhejiang Cancer Hospital
    Hangzhou, Zhejiang 310022, China
    • Xiaozhong Chen, MD · Contact · cxzfyun@sina.com · 86-571-88122098
    • Xiaozhong Chen, MD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 26, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02663440
Lead sponsor
Zhejiang Cancer Hospital
Responsible party
Sponsor
First posted
Jan 26, 2016
Start date
Jan 2016
Primary completion
Dec 2017 (estimated)
Last update
Jan 26, 2016
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

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