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

Glioblastoma Multiforme Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02663440
• Other study ID #: ZJZLYY-HN-2016-01
• Status: Recruiting
• Phase: Phase 2
• First received: January 18, 2016
• Last updated: January 21, 2016
• Start date: January 2016

Study information

• Verified date: January 2016
• Source: Zhejiang Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 41
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma Multiforme

Intervention

Radiation:
• Hypofractionated IMRT
Hypofractionated IMRT

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

Drug:
• Temozolomide
Temozolomide

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes