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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

Primary Purpose

Glioblastoma Multiforme

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Hypofractionated IMRT
Granulocyte-macrophage Colony-stimulating Factor
Temozolomide
Sponsored by
Zhejiang Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioblastoma Multiforme

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Zhejiang Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IMRT

Arm Description

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

Outcomes

Primary Outcome Measures

PFS

Secondary Outcome Measures

Full Information

First Posted
January 18, 2016
Last Updated
January 21, 2016
Sponsor
Zhejiang Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02663440
Brief Title
Trial of Hypofractionated Intensity Modulated Radiation Therapy With Temozolomide and Granulocyte-macrophage Colony-stimulating Factor for Patients With Newly Diagnosed Glioblastoma Multiforme
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhejiang Cancer Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma Multiforme

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IMRT
Arm Type
Experimental
Arm Description
Hypofractionated IMRT With Temozolomide and Granulocyte-macrophage Colony-stimulating Factor
Intervention Type
Radiation
Intervention Name(s)
Hypofractionated IMRT
Intervention Description
Hypofractionated IMRT
Intervention Type
Biological
Intervention Name(s)
Granulocyte-macrophage Colony-stimulating Factor
Intervention Description
Granulocyte-macrophage Colony-stimulating Factor
Intervention Type
Drug
Intervention Name(s)
Temozolomide
Intervention Description
Temozolomide
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaozhong Chen, MD
Phone
86-571-88122098
Email
cxzfyun@sina.com
First Name & Middle Initial & Last Name & Degree
Xiaozhong Chen, MD

12. IPD Sharing Statement

Learn more about this trial

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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