Treatment Strategy for Low-grade Gliomas
Overview
- Phase
- Phase 3
- Intervention
- Radiation therapy
- Conditions
- Astrocytomas
- Sponsor
- Sun Yat-sen University
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Efficacy of early radiation therapy in MRI-determined total resected LGGs: evaluated as 5-year progression-free survival.
- Status
- Terminated
- Last Updated
- 11 years ago
Overview
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.
Investigators
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
Arms & Interventions
Total resection with early radiation
Total resected LGGs treated with early radiation
Intervention: Radiation therapy
Residual LGGs with radiation
Residual LGGs treated with early radiation
Intervention: Radiation therapy
Residual LGGs with chemo
Residual LGGS treated with temozolomide
Intervention: Temozolomide
Outcomes
Primary Outcomes
Efficacy of early radiation therapy in MRI-determined total resected LGGs: evaluated as 5-year progression-free survival.
Time Frame: 10 years
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