Temozolomide 12 Cycles Versus 6 Cycles of Standard First-line Treatment in Patients With Glioblastoma.
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|ClinicalTrials.gov Identifier: NCT02209948|
Recruitment Status : Completed
First Posted : August 6, 2014
Results First Posted : January 12, 2021
Last Update Posted : January 12, 2021
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma||Drug: Temozolomide||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||166 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Trial Phase IIB Randomized, Multicenter, of Continuation or Non Continuation With 6 Cycles of Temozolomide After the First 6 Cycles of Standard First-line Treatment in Patients With Glioblastoma.|
|Actual Study Start Date :||August 22, 2014|
|Actual Primary Completion Date :||June 2019|
|Actual Study Completion Date :||June 14, 2019|
Those patients will take 6 additional Temozolomide cycles
|No Intervention: Without treatment|
- Progression Free Survival at 6 Month [ Time Frame: 6 month ]
Percentage of patients without progression of disease and time between start of treatment and progression of disease.
The progression disease is defined as the time from the date of randomization to the date of progression defined according to the RANO criteria.
- Number of Participants With Adverse Effects [ Time Frame: Through the whole study. 4 years ]Total number of patients presenting adverse events, stratified by type of event and grade. Adverse Events of special interest: Only relevant differences in toxicity by arm.
- Progresion Free Survival Median Values [ Time Frame: Through the whole study. 4 years. The median follow up for each patient was 33.4 months ]It will be measured following Response assessment in neuro-oncology (RANO) guidelines: progression-free survival
- Overall Survival [ Time Frame: Through the whole study. 4 years. The median follow up for each patient was 33.4 months ]Time between start of treatment and death
- Median Progression-free Survival (PFS) by Arm and MGMT Methylation Status [ Time Frame: Through the whole study. 4 years. The median follow up for each patient was 33.4 months ]Median Progression Free Survival depending on treatment arm in patients with MGMT methylation
- Median Overall Survival (OS) by Arm and MGMT Methylation Status [ Time Frame: Through the whole study. 4 years. The median follow up for each patient was 33.4 months ]Median OS depending on treatment arm in patients with methylated MGMT
- Translational Sub-study - Biomarkers: mutS Homolog 6 (MSH6) Immunoreactivity [ Time Frame: baseline ]partial immunoreactivity of MSH6 in patients by treatment arm. Tumor samples were stained by immuno-histochemical techniques.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02209948
|Study Chair:||Carmen Balañá, M.D.||Hospital Germans Trias i Pujol - ICO Badalona|
|Study Chair:||Mª Ángeles Vaz, M.D.||Hospital Universitario Ramon y Cajal|