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Treatment Strategy for Low-grade Gliomas

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ClinicalTrials.gov Identifier: NCT00897377
Recruitment Status : Terminated (Difficulty in recruiting patients)
First Posted : May 12, 2009
Last Update Posted : August 5, 2014
Sponsor:
Information provided by:
Sun Yat-sen University

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : December 2007

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Arms and Interventions
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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
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Primary Outcome Measures :
  1. Efficacy of early radiation therapy in MRI-determined total resected LGGs: evaluated as 5-year progression-free survival. [ Time Frame: 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. [ Time Frame: 10 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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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
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: August 5, 2014
Last Verified: May 2009

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