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  • CODEL

    Acronym: 

    CODEL

    ACTRN/NCT /ethics: 

    NCT00887146

    Scientific title: 

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

    Summary of trial and patient characteristics

    Cancer Type Brain & central nervous system
    Trial Type Treatment
    Phase Phase III Tumour Stream Glioma
    Age Range 18 years and older Cancer Stage Clinical Trials - Cancer Stage
    Sex Both Anticipated Start Date 2009-09-01
    Molecular Target Anticipated End Date 2018-12-01
    Cancer Type Brain & central nervous system
    Trial Type Treatment
    Phase Phase III
    Age Range 18 years and older
    Sex Both
    Molecular Target
    Tumour Stream Glioma
    Cancer Stage Clinical Trials - Cancer Stage
    Anticipated Start Date 2009-09-01
    Anticipated End Date 2018-12-01

    Trial Summary

    This study will be a randomized phase III for patients with newly diagnosed co-deleted 1p/19q anaplastic glioma or high risk low grade glioma. The trial will only enroll patients with 1p/19q co-deletion. This study includes two arms as described in the "Arms" section. A dynamic allocation procedure will be used to allocate an equal number of patients to different arms (Arms A:B = 1:1). This procedure will balance the marginal distributions of the stratification factors among arms. The stratification factors that will be used are cooperative groups (EORTC vs. all North American groups), age (? 50 vs. 50), performance score (ECOG 0-1 vs. 2), and tumor grade (anaplastic glioma vs. low grade glioma). The primary goal is to determine whether patients who receive radiotherapy with concomitant temozolomide (TMZ) followed by adjuvant temozolomide (RT + TMZ -- TMZ) (Arm B) have a marginally better progression free survival (PFS) as compared with patients who receive radiotherapy followed by PCV chemotherapy (RT -- PCV)(Arm A). Secondary Goals: Time to Progression - To determine whether patients who receive (RT + TMZ -- TMZ) have a significantly longer time to progression (clinical or radiographic progression) as compared with patients who receive radiotherapy followed by adjuvant PCV chemotherapy (RT -- PCV). Correlation between exploratory biomarkers and survival - To determine whether there is a difference in survival based on t(1;19)(q10, p10) translocation status and MGMT promoter hypermethylation status. Descriptive Comparisons of Additional Secondary Endpoints - To perform descriptive comparisons of additional secondary outcome endpoints, including overall survival, objective tumor response, prognostic factor analysis and quality of life. Toxicity - To determine the toxicity of the treatment in each arm and perform descriptive comparisons. Neurocognitive and Quality of Life (QOL) Effects - To determine the neurocognitive and QOL effects in patients treated on this protocol and correlate these results with outcome endpoints. Banking of Biospecimens and Neuroimaging Studies - To store blood products (i.e., plasma, DNA and buffy coat), tumor tissue and MRI/CT images for future scientific investigations. After completion of study treatment, patients are followed every 12 weeks for 1 year, then every 4 months for 2 years and then every 6 months until progressive disease or until the end of study participation.

    Lay Summary

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

    Sponsor / Cooperative group

    Alliance for Clinical Trials in Oncology National Cancer Institute (NCI) European Organisation for Research and Treatment Center (EORTC) NCIC Clinical Trials Group

    Participating Hospitals

    Hospital Clinical Trial Coordinator Email Phone Principal Investigator Recruitment Status
    Flinders Medical Centre Alex Scott-Hoy alex.scott-hoy@sa.gov.au 08 8204 4830 Ganessan Kichenadasse Not Yet Recruiting