We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Treatment Strategy for Low-grade Gliomas

This study has been terminated.
(Difficulty in recruiting patients)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00897377
First Posted: May 12, 2009
Last Update Posted: August 5, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sun Yat-sen University
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment Strategy for Low-grade Gliomas

Resource links provided by NLM:


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 ]
  • 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 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
Information from the National Library of Medicine

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

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 Submitted: May 8, 2009
First Posted: May 12, 2009
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