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
|
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Astrocytomas Oligodendrogliomas Oligoastrocytoma | Radiation: Radiation therapy Drug: Temozolomide | Phase 3 |
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 |

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 |
- 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 ]

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
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

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
China, Guangdong | |
Sun Yat-sen University | |
Guangzhou, Guangdong, China, 510060 |
Study Chair: | Zhongping Chen, M.D., Ph.D. | Sun Yat-sen University |
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 |