Treatment Strategy for Low-grade Gliomas

This study has been terminated.

(Difficulty in recruiting patients)

Sponsor:

Information provided by:

Sun Yat-sen University

ClinicalTrials.gov Identifier:

NCT00897377

First received: May 8, 2009

Last updated: August 4, 2014

Last verified: May 2009

History of Changes

Purpose

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.

Condition	Intervention	Phase
Astrocytomas Oligodendrogliomas Oligoastrocytoma	Radiation: Radiation therapy Drug: Temozolomide	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Treatment Strategy for Low-grade Gliomas

Resource links provided by NLM:

Drug Information available for: Temozolomide

Genetic and Rare Diseases Information Center resources: Oligodendroglioma Oligoastrocytoma Glioma Neuroepithelioma

U.S. FDA Resources

Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:

Efficacy of early radiation therapy in MRI-determined total resected LGGs: evaluated as 5-year progression-free survival. [ Time Frame: 10 years ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]


Estimated Enrollment:	500
Study Start Date:	December 2007

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	18 Years to 60 Years (Adult)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00897377

Locations


China, Guangdong
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

More Information


Responsible Party:	Zhongping CHEN, Department of Neurosurgery, Sun Yat-sen University Cancer Center
ClinicalTrials.gov Identifier:	NCT00897377 History of Changes
Other Study ID Numbers:	YP2008009
Study First Received:	May 8, 2009
Last Updated:	August 4, 2014
Health Authority:	China: Ministry of Health

Additional relevant MeSH terms:


Astrocytoma Oligodendroglioma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms	Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Temozolomide Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents

ClinicalTrials.gov processed this record on September 27, 2016

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