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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Glioblastoma | Drug: Temozolomide | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 166 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: Temozolomide
Those patients will take 6 additional Temozolomide cycles
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Drug: Temozolomide |
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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Ability to understand and sign the informed consent document .
- Age greater than or equal 18.
- Patients with glioblastoma according to WHO classification (glioblastoma ) who received chemo- radiotherapy and temozolomide -based chemotherapy ( Stupp scheme ) and have completed 6 cycles of adjuvant temozolomide (with or without bevacizumab) in the context of standard treatment without presenting progression of disease.
- Availability of tumor tissue from the first surgery for centralized histological review , for determining the MGMT study if you have not done in the center of origin. (If they were made in the center of origin the result of the center will be accepted ).
- Stable dose of dexamethasone in the inclusion never above corticoids dose received in cycle 6 of the adjuvant .
- Index greater than or equal 60 % Karnofsky.
- All patients must show no progression of disease in a brain nuclear magnetic resonance (NMR) as defined in RANO established criteria before randomization .
- Basal NMR study on a maximum of 6 weeks prior to inclusion, in which no progress is observed and is permitted to manage the care 6th cycle ( NMR performed after the 6th cycle of adjuvant is also acceptable as long as no progression was observed).
- Adequate bone marrow reserve : hematocrit greater or equal 29% , white blood cell> 3,000 , RAN greater or equal 1,500 cells / ul , platelets greater or equal 100,000 cells / ul.
- Creatinine <1.5 times the upper limit of normal (ULN) of the laboratory performing the analysis.
- Serum bilirubin <1.5 / ULN; SGOT , SGPT < 2.5 times the upper limit of normal of the laboratory performing the analysis. Serum < 3/ULN alkaline phosphatases .
- Effective contraceptive method in patients and their partners.
Exclusion Criteria:
- Less than 5 years of any previous invasive neoplasia. In situ cervical carcinoma or basal cell skin carcinoma accepted.
- Concomitant treatment with other investigational agents (other concomitant bevacizumab) .
- Presence of any clinically significant gastrointestinal abnormalities that may affect the decision , transit or absorption of study drug , such as the inability to take medication in tablets by mouth.
- Presence of any psychiatric or cognitive disorder that limits understanding or written informed consent and / or impair compliance with the requirements of this protocol.
- Concurrent disease that prevents the continuation of temozolomide treatment.
- Presence of leptomeningeal dissemination.
- Pregnant or breastfeeding.
- Positive patients receiving combination antiretroviral therapy in HIV

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 |
Documents provided by Grupo Español de Investigación en Neurooncología:
Responsible Party: | Grupo Español de Investigación en Neurooncología |
ClinicalTrials.gov Identifier: | NCT02209948 |
Other Study ID Numbers: |
GEINO 14-01 2014-000838-39 ( EudraCT Number ) |
First Posted: | August 6, 2014 Key Record Dates |
Results First Posted: | January 12, 2021 |
Last Update Posted: | January 12, 2021 |
Last Verified: | December 2020 |
Glioblastoma Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms |
Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Temozolomide Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |