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A Phase III Trial on Adjuvant Temozolomide With or Without Interferon-alpha in Newly Diagnosed High-grade Gliomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01765088
Recruitment Status : Unknown
Verified February 2018 by Zhongping Chen, Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : January 10, 2013
Last Update Posted : February 23, 2018
Sponsor:
Information provided by (Responsible Party):
Zhongping Chen, Sun Yat-sen University

Tracking Information
First Submitted Date  ICMJE January 7, 2013
First Posted Date  ICMJE January 10, 2013
Last Update Posted Date February 23, 2018
Study Start Date  ICMJE September 2012
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 8, 2013)
Over-all survival [ Time Frame: 5-year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 8, 2013)
Quality of life [ Time Frame: 5-year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase III Trial on Adjuvant Temozolomide With or Without Interferon-alpha in Newly Diagnosed High-grade Gliomas
Official Title  ICMJE A Phase III Trial on Adjuvant Standard Temozolomide Chemotherapy With or Without Interferon-alpha in Newly Diagnosed High-grade Gliomas
Brief 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.
Detailed 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Anaplastic Oligoastrocytoma
  • Anaplastic Astrocytoma
  • Glioblastoma
Intervention  ICMJE
  • Drug: Temozolomide
    dosed at 200 mg/m2 (150 mg/m2 for the first cycle) daily for 5 consecutive days, repeated every 28 days
    Other Name: Temodar
  • Drug: α-IFN
    3mIU (3million) D1,3,5
    Other Name: INTRONA
Study Arms  ICMJE
  • Active Comparator: temozolomide
    Four weeks after radiotherapy, patients will be received 6 cycle of temozolomide (150 mg/m^2 daily on Days 1-5 of each 28 day study cycle and 200 mg/m^2 daily of subsequent cycles)
    Intervention: Drug: Temozolomide
  • Experimental: temozolomide +α-IFN
    Four weeks after radiotherapy, patients will be received 6 cycle of temozolomide plus α-IFN α-IFN:3mIU (3million) Day1,3,5 of each 28 day TMZ:150 mg/m^2 daily on Days 2-6 of each 28 day study cycle and 200 mg/m^2 daily of subsequent cycles
    Interventions:
    • Drug: Temozolomide
    • Drug: α-IFN
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 8, 2013)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
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 NCT01765088
Other Study ID Numbers  ICMJE CSNO2012001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Zhongping Chen, Sun Yat-sen University
Study Sponsor  ICMJE Sun Yat-sen University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Sun Yat-sen University
Verification Date February 2018

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