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Treatment Strategy for Low-Grade Gliomas

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Sun Yat-sen University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT00897377
First received: May 8, 2009
Last updated: May 11, 2009
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:

  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 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:

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

Contacts
Contact: Zhongping Chen, M.D., Ph.D +86-20-87343310 chenzp57@mail.sysu.edu.cn
Contact: Ke Sai, M.D. +86-20-87343309 saike@mail.sysu.edu.cn

Locations
China, Guangdong
Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Zhongping Chen, M.D., Ph.D.     +86-20-87343310     chenzp57@mail.sysu.edu.cn    
Contact: Ke Sai, M.D.     +86-20-87343309     saike@mail.sysu.edu.cn    
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Study Chair: Zhongping Chen, M.D., Ph.D. Sun Yat-sen University
  More Information

No publications provided

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: May 11, 2009
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
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013