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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01765088
Other study ID # CSNO2012001
Secondary ID
Status Recruiting
Phase Phase 3
First received January 7, 2013
Last updated February 21, 2018
Start date September 2012
Est. completion date December 2019

Study information

Verified date February 2018
Source Sun Yat-sen University
Contact Zhong-ping CHEN, MD, PhD
Phone +86-20-87343310
Email chenzhp@sysucc.org.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is being conducted to help determine whether the addition of Interferon-alpha(α-IFN),which were determined sensitized the activity of Temozolomide(TMZ) in vivo and vitro, when given along with temozolomide during the monthly cycles that follow radiation, is able to delay tumor growth, shrink tumors, or impact how long people with newly diagnosed high-grade glioma.


Description:

This study is being conducted to help determine whether the addition of Interferon-alpha(α-IFN),which were determined sensitized the activity of Temozolomide(TMZ) in vivo and vitro, when given along with temozolomide during the monthly cycles that follow radiation, is able to delay tumor growth, shrink tumors, or impact how long people with newly diagnosed high-grade glioma. Four weeks after radiotherapy, newly diagnosed WHO III-IV glioma patients will be randomised into two groups: TMZ group or TMZ+ α-IFN groups.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date December 2019
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Age: 18 years to 75 years

- newly diagnosed WHO III-IV glioma after operation and radiotherapy

- Karnofsky Performance Score = 60

- Adequate bone marrow, liver and renal function

- Ability of subject to understand character and individual consequences of the clinical trial

- Written informed consent

- anticipating survival =2 months

Exclusion Criteria:

- Refusal to participate the study

- Known hypersensitivity or contraindication to temozolomide

- Incompletely radiation

- Pregnant or lactating females

- Malignant tumor other than brain tumor

- Contraindicated for MRI examination

- Unable to comply with the follow-up studies of this trial

- Purulent and chronic infected wounds

- Uncontrolled psychotic disorders or epilepsy

Study Design


Intervention

Drug:
Temozolomide
dosed at 200 mg/m2 (150 mg/m2 for the first cycle) daily for 5 consecutive days, repeated every 28 days
a-IFN
3mIU (3million) D1,3,5

Locations

Country Name City State
China Sun Yat-sen University Cancer Center Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Over-all survival 5-year
Secondary Quality of life 5-year
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