Treatment Strategy for Low-grade Gliomas

NCT ID: NCT00897377

Last Updated: 2014-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Brief Summary

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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:

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.

Detailed Description

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Conditions

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Astrocytomas Oligodendrogliomas Oligoastrocytoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Total resection with early radiation

Total resected LGGs treated with early radiation

Group Type EXPERIMENTAL

Radiation therapy

Intervention Type RADIATION

Total resection without radiation

Total resected LGGs treated without radiation

Group Type NO_INTERVENTION

No interventions assigned to this group

Residual LGGs with radiation

Residual LGGs treated with early radiation

Group Type EXPERIMENTAL

Radiation therapy

Intervention Type RADIATION

Residual LGGs with chemo

Residual LGGS treated with temozolomide

Group Type EXPERIMENTAL

Temozolomide

Intervention Type DRUG

Interventions

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Radiation therapy

Intervention Type RADIATION

Temozolomide

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Department of Neurosurgery, Sun Yat-sen University Cancer Center

Principal Investigators

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Zhongping Chen, M.D., Ph.D.

Role: STUDY_CHAIR

Sun Yat-sen University

Locations

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Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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YP2008009

Identifier Type: -

Identifier Source: org_study_id

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