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Treatment Strategy for Low-grade Gliomas

Treatment Strategy for Low-grade Gliomas

Status
Terminated
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00897377
Enrollment
500
Registered
2009-05-12
Start date
2007-12-31
Completion date
Unknown
Last updated
2014-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Astrocytomas, Oligoastrocytoma, Oligodendrogliomas

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.

Interventions

RADIATIONRadiation therapy
DRUGTemozolomide

Sponsors

Sun Yat-sen University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
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

Design outcomes

Primary

MeasureTime frame
Efficacy of early radiation therapy in MRI-determined total resected LGGs: evaluated as 5-year progression-free survival.10 years
Efficacy of early radiation therapy vs. initial chemotherapy with temozolomide in LGGs without total resection: evaluated as 5-year progression-free survival.10 years

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026