Treatment Strategy for Low-grade Gliomas

Phase 3

Terminated

• Conditions: Oligodendrogliomas; Astrocytomas; Oligoastrocytoma
• Interventions: Radiation: Radiation therapy; Drug: Temozolomide

• Registration Number: NCT00897377
• Lead Sponsor: Sun Yat-sen University

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:

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Status Verified: 2009-05
• Study First Submitted: 2009-05-08
• Study First Submitted QC: 2009-05-11
• Study First Posted: 2009-05-12
• Last Update Submitted: 2014-08-04
• Last Update Posted: 2014-08-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Residual LGGs with radiation	Radiation therapy	Residual LGGs treated with early radiation
Residual LGGs with chemo	Temozolomide	Residual LGGS treated with temozolomide
Total resection with early radiation	Radiation therapy	Total resected LGGs treated with early radiation

Primary Outcome Measures

Name	Time	Method
Efficacy of early radiation therapy in MRI-determined total resected LGGs: evaluated as 5-year progression-free survival.	10 years
Efficacy of early radiation therapy vs. initial chemotherapy with temozolomide in LGGs without total resection: evaluated as 5-year progression-free survival.	10 years

Trial Locations

Locations (1)

Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China