Back to resultsTreatment Strategy for Low-grade Gliomas
Primary Purpose
Astrocytomas, Oligodendrogliomas, Oligoastrocytoma
Status
Terminated
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Radiation therapy
Temozolomide
Sponsored by
About this trial
This is an interventional treatment trial for Astrocytomas
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed newly diagnosed low-grade gliomas
- Karnofsky performance status of 60 or more
Exclusion Criteria:
- Previous history of radiation therapy or chemotherapy for gliomas
- Pregnant or breast feeding
- Diagnosis of another malignancy may exclude subject from study
- Evidence or history of bleeding diathesis
- Evidence or history of hypersensitivity to temozolomide
Sites / Locations
- Sun Yat-sen University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
No Intervention
Experimental
Experimental
Arm Label
Total resection with early radiation
Total resection without radiation
Residual LGGs with radiation
Residual LGGs with chemo
Arm Description
Total resected LGGs treated with early radiation
Total resected LGGs treated without radiation
Residual LGGs treated with early radiation
Residual LGGS treated with temozolomide
Outcomes
Primary Outcome Measures
Efficacy of early radiation therapy in MRI-determined total resected LGGs: evaluated as 5-year progression-free survival.
Efficacy of early radiation therapy vs. initial chemotherapy with temozolomide in LGGs without total resection: evaluated as 5-year progression-free survival.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00897377
Brief Title
Treatment Strategy for Low-grade Gliomas
Official Title
Treatment Strategy for Low-grade Gliomas
Study Type
Interventional
2. Study Status
Record Verification Date
May 2009
Overall Recruitment Status
Terminated
Why Stopped
Difficulty in recruiting patients
Study Start Date
December 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Although the prognosis of patients with low-grade glioma (LGG) is generally good, recurrence seems unavoidable in some patients because of the infiltrative growth of the tumors. How to treat LGGs is still under controversy. The role of radiation therapy and chemotherapy in the treatment of LGG need to be further investigated. The purpose of this study is the following:
to investigate the role of early radiation therapy in MRI-determined total resected LGGs;
to compare the efficacy of early radiation therapy and that of initial chemotherapy in the LGGs without total resection.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Astrocytomas, Oligodendrogliomas, Oligoastrocytoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Total resection with early radiation
Arm Type
Experimental
Arm Description
Total resected LGGs treated with early radiation
Arm Title
Total resection without radiation
Arm Type
No Intervention
Arm Description
Total resected LGGs treated without radiation
Arm Title
Residual LGGs with radiation
Arm Type
Experimental
Arm Description
Residual LGGs treated with early radiation
Arm Title
Residual LGGs with chemo
Arm Type
Experimental
Arm Description
Residual LGGS treated with temozolomide
Intervention Type
Radiation
Intervention Name(s)
Radiation therapy
Intervention Type
Drug
Intervention Name(s)
Temozolomide
Primary Outcome Measure Information:
Title
Efficacy of early radiation therapy in MRI-determined total resected LGGs: evaluated as 5-year progression-free survival.
Time Frame
10 years
Title
Efficacy of early radiation therapy vs. initial chemotherapy with temozolomide in LGGs without total resection: evaluated as 5-year progression-free survival.
Time Frame
10 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed newly diagnosed low-grade gliomas
Karnofsky performance status of 60 or more
Exclusion Criteria:
Previous history of radiation therapy or chemotherapy for gliomas
Pregnant or breast feeding
Diagnosis of another malignancy may exclude subject from study
Evidence or history of bleeding diathesis
Evidence or history of hypersensitivity to temozolomide
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhongping Chen, M.D., Ph.D.
Organizational Affiliation
Sun Yat-sen University
Official's Role
Study Chair
Facility Information:
Facility Name
Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
12. IPD Sharing Statement
Learn more about this trial
Treatment Strategy for Low-grade Gliomas
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