Ignite Creation Date:
2024-05-06 @ 12:18 AM
Last Modification Date:
2024-10-26 @ 10:47 AM
Study NCT ID:
NCT01534845
Status:
UNKNOWN
Last Update Posted:
2015-07-09
First Post:
2012-02-06
Brief Title:
Efficacy Study of Radiotherapy Alone Versus CCRT With Temozolomide in Grade III Gliomas Without 1p19q Codeletion
Sponsor:
Jong Hoon Kim
Organization:
Asan Medical Center
Study Overview
Official Title:
A Randomized Phase 2 Study to Evaluate the Efficacy Between Only Radiotherapy Versus CCRT With Temozolomide in Newly Diagnosed Grade III Gliomas Without 1p19q Codeletion
Status:
UNKNOWN
Status Verified Date:
2015-07
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 1p19q 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 1p19q
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
2 Codeletion of chromosome 1p19q 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 1p19q
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
Detailed Description:
The role of chemotherapy for gliomas has been recently reappraised by the advent of temozolomide especially for glioblastomas and further investigation is now being directed to unveiling its optimal indications dosing protocols and the most relevant prognostic factors Meanwhile the management of anaplastic gliomas of WHO grade 3 anaplastic astrocytomas anaplastic oligodendrogliomas and anaplastic oligoastrocytomas 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 Moreover WHO grade 3 gliomas are now known to consist of heterogeneous groups of different histologic features biological behaviors and prognoses Accordingly relevant molecular markers are appreciated with the growing body of data that showing their implications on response to therapy and survival including codeletion of chromosome 1p19q methylation status of methylguanine methyl transferase MGMT and isocitrate dehydrogenase IDH mutation14-611 Among those codeletion of chromosome 1p19q is considered the most important marker of prognostic significance in WHO grade 3 gliomas
One recent Korean prospective cohort study showed the potential survival benefit and safety of concurrent chemoradiotherapy with temozolomide followed by adjuvant temozolomide for WHO grade 3 gliomas In this study however the role of molecular markers such as codeletion of chromosome 1p19q and MGMT methylation could not be determined because of small number of patients available These results prompted this Korean group 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 1p19q The basic concept of the present clinical trial is a subgroup with expected worse prognosis according to the status of chromosome 1p19q ie one without codeletion of chromosome 1p19q is to be managed more aggressively to investigate the role of temozolomide An aggressive therapy surgery concurrent chemoradiotherapy with temozolomide followed by adjuvant temozolomide will be compared to the conventional arm surgery radiotherapy only in terms of its efficacy and safety for WHO grade 3 gliomas without chromosome 1p19q codeletion 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 Until now there have been no such trials examining the efficacy and safety of temozolomide for WHO grade 3 gliomas based on prospective molecular stratification
One recent Korean prospective cohort study showed the potential survival benefit and safety of concurrent chemoradiotherapy with temozolomide followed by adjuvant temozolomide for WHO grade 3 gliomas In this study however the role of molecular markers such as codeletion of chromosome 1p19q and MGMT methylation could not be determined because of small number of patients available These results prompted this Korean group 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 1p19q The basic concept of the present clinical trial is a subgroup with expected worse prognosis according to the status of chromosome 1p19q ie one without codeletion of chromosome 1p19q is to be managed more aggressively to investigate the role of temozolomide An aggressive therapy surgery concurrent chemoradiotherapy with temozolomide followed by adjuvant temozolomide will be compared to the conventional arm surgery radiotherapy only in terms of its efficacy and safety for WHO grade 3 gliomas without chromosome 1p19q codeletion 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 Until now there have been no such trials examining the efficacy and safety of temozolomide for WHO grade 3 gliomas based on prospective molecular stratification
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None