Efficacy Study of Radiotherapy Alone Versus CCRT With Temozolomide in Grade III Gliomas Without 1p/19q Codeletion
Status:
Unknown status
Trial end date:
2017-02-01
Target enrollment:
Participant gender:
Summary
1. The management of anaplastic gliomas of WHO grade 3 is currently largely based on
surgery followed by radiotherapy, of which prognosis remains still dismal with the
median survival of 2-5 years. To date, the benefit of chemo for WHO grade 3 gliomas is
unclear of modest at best with conventional cytotoxic agents, and the role of
temozolomide for these entities still is not elucidated.
2. Codeletion of chromosome 1p/19q is considered the most important marker of prognostic
significance in WHO grade 3 gliomas.
3. To project a randomized phase 2 screening trial examining the efficacy of concurrent
chemoradiotherapy with temozolomide followed by adjuvant temozolomide for WHO grade 3
gliomas without codeletion of chromosome 1p/19q.
4. The prognostic significance of methylation status of MGMT and IDH1 mutation as molecular
markers will be also assessed in each arm as key secondary analysis.