Treatment Strategy for Low-grade Gliomas

Phase 3TerminatedNCT00897377

Sun Yat-sen University500 enrolled

Overview

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: 1. to investigate the role of early radiation therapy in MRI-determined total resected LGGs; 2. to compare the efficacy of early radiation therapy and that of initial chemotherapy in the LGGs without total resection.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

500

Conditions

Astrocytomas Oligodendrogliomas Oligoastrocytoma

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

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.