Radiation Therapy With Concomitant and Adjuvant Temozolomide Versus Radiation Therapy With Adjuvant PCV Chemotherapy in Patients With Anaplastic Glioma or Low Grade Glioma - Trial ANZCTR12620000402943

Timeline & Enrollment

Primary Outcome

Progression-free survival - The distribution of progression free survival for Arms A and B will be estimated using the Kaplan-Meier method. The hazard ratios and median progression free survival (PFS) will be estimated with their confidence intervals. The Cox proportional hazards model will be used to assess whether the distributions of progression survival times differ with respect to treatment regimen having adjusted for all stratification factors (cooperative groups, age, and performance score). Both non-inferiority and superiority will be tested in this trial for the primary goal and no multiple-comparison adjustment will be considered. Data to be used for the Kaplan meier method will be sourced from scan results as well as evidence of clinical progression from investigator assessment/medical records.

Summary

The aim of this study is to evaluate whether giving radiation with concomitant and adjuvant temozolomide versus radiation with adjuvant PCV is more effective in treating anaplastic glioma or low grade glioma. Who is it for? You may eligible for this study if you are 18 years or older and newly diagnosed with Glioma with tumor tissue determined to have local 1p/9q co-deletion and yet to receive radiation or chemotherapy Study details Participants will be randomly allocated (50/50 chance) to either ARM A or ARM B. 1.Participants in Arm A will undergo radiotherapy on days 1-5 for 5-7 weeks. Patients also receive procarbazine hydrochloride orally on days 8-21, lomustine orally on day 1 and vincristine sulfate intravenously on days 8 and 29 of courses 3-8. Treatment repeats every 6-7 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. 2.Participants allocated to Arm B will undergo radiotherapy and receive temozolomide orally once daily on days 1-5 for 5-7 weeks. Beginning 4 weeks after completion of concurrent chemoradiotherapy, patients receive adjuvant temozolomide once daily on days 1-5. Treatment with adjuvant temozolomide repeats every 4 weeks for 6-12 courses in the absence of disease progression and unacceptable toxicity. Involvement in the study may include blood tests, urine tests, medical imaging scans, quality of life questionnaires, pregnancy test, neurocognitive exam and completion of medication diary. It is hoped this study can provide greater insight into the most effective treatment combination for patients with Glioma

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