Treatment Strategy for Low-grade Gliomas

Oligoastrocytoma Clinical Trial

Official title:

Treatment Strategy for Low-grade Gliomas

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00897377
• Other study ID #: YP2008009
• Status: Terminated
• Phase: Phase 3
• First received: May 8, 2009
• Last updated: August 4, 2014
• Start date: December 2007

Study information

• Verified date: May 2009
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 500
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Astrocytoma
• Astrocytomas
• Oligoastrocytoma
• Oligodendroglioma
• Oligodendrogliomas

Intervention

Radiation:
• Radiation therapy

Drug:
• Temozolomide

Locations

Country	Name	City	State
China	Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of early radiation therapy in MRI-determined total resected LGGs: evaluated as 5-year progression-free survival.		10 years	No
Primary	Efficacy of early radiation therapy vs. initial chemotherapy with temozolomide in LGGs without total resection: evaluated as 5-year progression-free survival.		10 years	No