NCT00897377

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. 1.to investigate the role of early radiation therapy in MRI-determined total resected LGGs;
  2. 2.to compare the efficacy of early radiation therapy and that of initial chemotherapy in the LGGs without total resection.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P50-P75 for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 8, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
Last Updated

August 5, 2014

Status Verified

May 1, 2009

First QC Date

May 8, 2009

Last Update Submit

August 4, 2014

Conditions

AstrocytomasOligodendrogliomasOligoastrocytoma

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (4)

Total resection with early radiation

EXPERIMENTAL

Total resected LGGs treated with early radiation

Radiation: Radiation therapy

Total resection without radiation

NO INTERVENTION

Total resected LGGs treated without radiation

Residual LGGs with radiation

EXPERIMENTAL

Residual LGGs treated with early radiation

Radiation: Radiation therapy

Residual LGGs with chemo

EXPERIMENTAL

Residual LGGS treated with temozolomide

Drug: Temozolomide

Interventions

Radiation therapyRADIATION
Residual LGGs with radiationTotal resection with early radiation
TemozolomideDRUG
Residual LGGs with chemo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Histologically confirmed newly diagnosed low-grade gliomas
  • Karnofsky performance status of 60 or more

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

AstrocytomaOligodendroglioma

Interventions

RadiotherapyTemozolomide

Condition Hierarchy (Ancestors)

GliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

TherapeuticsDacarbazineTriazenesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Zhongping Chen, M.D., Ph.D.

    Sun Yat-sen University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 8, 2009

First Posted

May 12, 2009

Study Start

December 1, 2007

Last Updated

August 5, 2014

Record last verified: 2009-05

Locations

CN(1)