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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

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.

Condition or disease Intervention/treatment Phase
Glioblastoma Multiforme Radiation: Hypofractionated IMRT Biological: Granulocyte-macrophage Colony-stimulating Factor Drug: Temozolomide Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 41 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2016
Estimated Primary Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: IMRT
Hypofractionated IMRT With Temozolomide and Granulocyte-macrophage Colony-stimulating Factor
Radiation: Hypofractionated IMRT
Hypofractionated IMRT

Biological: Granulocyte-macrophage Colony-stimulating Factor
Granulocyte-macrophage Colony-stimulating Factor

Drug: Temozolomide
Temozolomide




Primary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02663440


Locations
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China, Zhejiang
Zhejiang Cancer Hospital Recruiting
Hangzhou, Zhejiang, China, 310022
Contact: Xiaozhong Chen, MD    86-571-88122098    cxzfyun@sina.com   
Principal Investigator: Xiaozhong Chen, MD         
Sponsors and Collaborators
Zhejiang Cancer Hospital

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Responsible Party: Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier: NCT02663440     History of Changes
Other Study ID Numbers: ZJZLYY-HN-2016-01
First Posted: January 26, 2016    Key Record Dates
Last Update Posted: January 26, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Temozolomide
Sargramostim
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs