Treatment Strategy for Low-grade Gliomas

August 4, 2014 updated by: Sun Yat-sen University

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Sun Yat-sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy of early radiation therapy in MRI-determined total resected LGGs: evaluated as 5-year progression-free survival.
Time Frame: 10 years
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
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Study Chair: Zhongping Chen, M.D., Ph.D., Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Study Registration Dates

First Submitted

May 8, 2009

First Submitted That Met QC Criteria

May 11, 2009

First Posted (Estimate)

May 12, 2009

Study Record Updates

Last Update Posted (Estimate)

August 5, 2014

Last Update Submitted That Met QC Criteria

August 4, 2014

Last Verified

May 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YP2008009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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