ActivePhase 3ACTRN12607000427471

Radiation Therapy or Temozolomide in Treating Patients With Gliomas

Trans Tasman Radiation Oncology Group (TROG) 06.01 - Primary Chemotherapy With Temozolomide Versus Radiotherapy in Patients With Low Grade Gliomas After Stratification for Genetic 1p Loss: A Phase III Study to demonstrate a difference in progression free survival.


Sponsor

European Organisation for Research and Tretment of Cancer (EORTC)

Enrollment

699 participants

Start Date

Aug 17, 2005

Study Type

Interventional

Conditions

Summary

A randomized study to demonstrate a difference in progression-free survival (PFS) for primary treatment with temozolomide in order to assess: whether PFS and OS can be prolonged by primary chemotherapy with temozolomide, whether the incidence of late toxicity can be decreased by using primary chemotherapy, the toxicity profile of the two treatments and the quality of life of the patients The impact of 1p deletions in low-grade gliomas: prognostic effect of tumors with deletion on PFS overall and by treatment group. Benefit for patients with LGGs and deletions treated with TMZ compared to radiotherapy alone with respect to survival. Interaction between treatment and cytogenetic features.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study compares radiation therapy with the chemotherapy drug temozolomide for treating low-grade brain tumors (gliomas). It is open to adults aged 18 and older with confirmed low-grade glioma that needs treatment. Participants will be randomly assigned to receive either radiation or temozolomide and be followed for tumor response and quality of life.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Arm B: Temozolomide administered orally 75 mg/m2 daily x 21 days (one cycle), q 28 days until progression or for max. 12 cycles (experimental arm)

Arm B: Temozolomide administered orally 75 mg/m2 daily x 21 days (one cycle), q 28 days until progression or for max. 12 cycles (experimental arm)


Locations(34)

Belgium

France

Netherlands

Switzerland

Canada

Austria

Germany

Israel

Spain

Hungary

United Kingdom

Portugal

Egypt

Sweden

Luxembourg

Singapore

New Zealand

Belgium

France

Netherlands

Switzerland

Canada

Austria

Germany

Israel

Spain

Hungary

United Kingdom

Portugal

Egypt

Sweden

Luxembourg

Singapore

New Zealand

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ACTRN12607000427471


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