Treatment Strategy for Low-grade Gliomas

• Sponsor: Sun Yat-sen University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00897377
• Collaborator: (none)
• Enrollment: 500
• Location: 1
• Arms: 4

Study Details

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:

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.

Condition or Disease	Intervention/Treatment	Phase
Astrocytomas; Oligodendrogliomas; Oligoastrocytoma	Radiation: Radiation therapy; Drug: Temozolomide	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 500 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Treatment Strategy for Low-grade Gliomas
• Study Start Date: Dec 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Total resection with early radiation Total resected LGGs treated with early radiation	Radiation: Radiation therapy
No Intervention: Total resection without radiation Total resected LGGs treated without radiation
Experimental: Residual LGGs with radiation Residual LGGs treated with early radiation	Radiation: Radiation therapy
Experimental: Residual LGGs with chemo Residual LGGS treated with temozolomide	Drug: Temozolomide

Outcome Measures

Primary Outcome Measures

1. Efficacy of early radiation therapy in MRI-determined total resected LGGs: evaluated as 5-year progression-free survival. [10 years]

2. Efficacy of early radiation therapy vs. initial chemotherapy with temozolomide in LGGs without total resection: evaluated as 5-year progression-free survival. [10 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sun Yat-sen University	Guangzhou	Guangdong	China	510060

Sponsors and Collaborators

• Sun Yat-sen University

Investigators

• Study Chair: Zhongping Chen, M.D., Ph.D., Sun Yat-sen University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00897377
• Other Study ID Numbers: YP2008009
• First Posted: May 12, 2009
• Last Update Posted: Aug 5, 2014
• Last Verified: May 1, 2009

• Additional relevant MeSH terms: Astrocytoma; Oligodendroglioma; Temozolomide

Study Results

No Results Posted as of Aug 5, 2014