Spots Global Cancer Trial Database for Efficacy and Safety Study of Lomustine/Temozolomide Combination Therapy vs. Standard Therapy for Glioblastoma Patients
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Trial Identification
Brief Title: Efficacy and Safety Study of Lomustine/Temozolomide Combination Therapy vs. Standard Therapy for Glioblastoma Patients
Official Title: Phase III Trial of CCNU/Temozolomide (TMZ) Combination Therapy vs. Standard TMZ Therapy for Newly Diagnosed MGMT-methylated Glioblastoma Patients
Study ID: NCT01149109
Conditions
Study Description
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 14.6 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 CCNU/TMZ in a randomized multicenter phase III setting against standard therapy. In case the projected phase III trial confirms the phase II data, CCNU/TMZ 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 CCNU/TMZ (mOS in the mMGMT group 34 months, in the non-mMGMT group 12.5 months; Glas et al., 2009) while patients with a non-methylated MGMT did not have any benefit, the trial is restricted to mMGMT patients.The CeTeG trial randomizes in a 1:1 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 CCNU/TMZ therapy (6 courses à 6 weeks). Both arms include standard radiotherapy (RT) of the tumor site (30 x 2 Gy). Assuming that CCNU/TMZ therapy increases the median overall survival (mOS) from 48.9% (standard TMZ) to 70% (CCNU/TMZ; 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:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Depatment of Neurosurgery, Charité, University Hospital Berlin, Berlin, , Germany
Department of Neurology, University Hospital Bochum, Bochum, , Germany
Department of Neurology, University Hospital Bonn, Bonn, , Germany
Department of Neurosurgery, University Hospital Cologne, Cologne, , Germany
Department of Neurosurgery, University Hospital Dresden, Dresden, , Germany
Department of Neurosurgery, University Hospital Duesseldorf, Duesseldorf, , Germany
Department of Neurosurgery, University Hospital Frankfurt, Frankfurt, , Germany
Department of Radiooncology, University Hospital Leipzig, Leipzig, , Germany
Department of Neurosurgery, University of Heidelberg, Medical Faculty of Mannheim, Mannheim, , Germany
Department of Neurosurgery, University Hospital Muenster, Muenster, , Germany
Department of Neurosurgery, University Hospital Munich (LMU), Munich, , Germany
Department of Neurology, University Hospital Regensburg, Regensburg, , Germany
Contact Details
Name: Ulrich Herrlinger, Prof. Dr.
Affiliation: Division of Neurooncology, Departement of Neurology, University Hospital Bonn
Role: STUDY_DIRECTOR
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