Ignite Creation Date:
2024-05-05 @ 10:35 PM
Last Modification Date:
2024-10-26 @ 10:21 AM
Study NCT ID:
NCT01149109
Status:
COMPLETED
Last Update Posted:
2017-06-14
First Post:
2010-06-14
Brief Title:
Efficacy and Safety Study of LomustineTemozolomide Combination Therapy vs Standard Therapy for Glioblastoma Patients
Sponsor:
University Hospital Bonn
Organization:
University Hospital Bonn
Study Overview
Official Title:
Phase III Trial of CCNUTemozolomide TMZ Combination Therapy vs Standard TMZ Therapy for Newly Diagnosed MGMT-methylated Glioblastoma Patients
Status:
COMPLETED
Status Verified Date:
2017-06
Last Known Status:
None
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:
CeTeG
Brief Summary:
The prognosis of patients with newly diagnosed glioblastoma is dismal despite recent therapeutic improvements Using standard therapy with temozolomide TMZ and radiotherapy 60 Gy the median overall survival time mOS is 146 months Stupp et al 2005 Since in a previous non-randomized bicentric phase II trial primary combination chemotherapy with lomustine CCNU and TMZ was highly effective mOS 23 months UKT-03 trial Herrlinger et al 2006 Glas et al 2009 the proposed trial further investigates the efficacy of CCNUTMZ in a randomized multicenter phase III setting against standard therapy In case the projected phase III trial confirms the phase II data CCNUTMZ combination would be significantly better than TMZ monotherapy and would thus be the new standard treatment for newly diagnosed GBM patients with a methylated MGMT promotor Thus this trial has the potential to profoundly change the standard therapy of this most aggressive brain tumor Since in the previous trial only patients with a methylated MGMT mMGMT promoter had a benefit from CCNUTMZ mOS in the mMGMT group 34 months in the non-mMGMT group 125 months Glas et al 2009 while patients with a non-methylated MGMT did not have any benefit the trial is restricted to mMGMT patientsThe CeTeG trial randomizes in a 11 fashion newly diagnosed GBM patients 18-70 years for either standard TMZ therapy concomitant and 6 courses à 4 weeks of adjuvant TMZ therapy or experimental CCNUTMZ therapy 6 courses à 6 weeks Both arms include standard radiotherapy RT of the tumor site 30 x 2 Gy Assuming that CCNUTMZ therapy increases the median overall survival mOS from 489 standard TMZ to 70 CCNUTMZ 75 in the previous phase II trial Glas et al 2009 2 x 68 patients have to be accrued Patients will be accrued over 24 months and each patient will be followed for at least 24 months adding up to a total minimal duration of the time from first patient in until the end of the follow-up time of 48 months The primary endpoint is overall survival secondary endpoints include progression-free survival response rate acute and late toxicity and quality of life
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2009-011252-22 | EUDRACT_NUMBER | None | None |