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

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ClinicalTrials.gov Identifier: NCT02663440
Recruitment Status : Unknown
Verified January 2016 by Zhejiang Cancer Hospital.
Recruitment status was:  Recruiting
First Posted : January 26, 2016
Last Update Posted : January 26, 2016
Sponsor:
Information provided by (Responsible Party):
Zhejiang Cancer Hospital

Tracking Information
First Submitted Date  ICMJE January 18, 2016
First Posted Date  ICMJE January 26, 2016
Last Update Posted Date January 26, 2016
Study Start Date  ICMJE January 2016
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 21, 2016)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of Hypofractionated Intensity Modulated Radiation Therapy With Temozolomide and Granulocyte-macrophage Colony-stimulating Factor for Patients With Newly Diagnosed Glioblastoma Multiforme
Official Title  ICMJE Not Provided
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Glioblastoma Multiforme
Intervention  ICMJE
  • Radiation: Hypofractionated IMRT
    Hypofractionated IMRT
  • Biological: Granulocyte-macrophage Colony-stimulating Factor
    Granulocyte-macrophage Colony-stimulating Factor
  • Drug: Temozolomide
    Temozolomide
Study Arms  ICMJE Experimental: IMRT
Hypofractionated IMRT With Temozolomide and Granulocyte-macrophage Colony-stimulating Factor
Interventions:
  • Radiation: Hypofractionated IMRT
  • Biological: Granulocyte-macrophage Colony-stimulating Factor
  • Drug: Temozolomide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 21, 2016)
41
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02663440
Other Study ID Numbers  ICMJE ZJZLYY-HN-2016-01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Zhejiang Cancer Hospital
Study Sponsor  ICMJE Zhejiang Cancer Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Zhejiang Cancer Hospital
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP