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 :
Recruiting
First Posted : August 6, 2014
Last Update Posted : August 3, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Glioblastoma | Drug: Temozolomide | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 160 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 : | July 2014 |
Estimated Primary Completion Date : | December 2018 |
Estimated Study Completion Date : | January 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: Temozolomide
Those patients will take 6 additional Temozolomide cycles
|
Drug: Temozolomide |
No Intervention: Without treatment |
- Progression free survival at 6 month [ Time Frame: 6 month ]Number of patients (proportion) without progression of disease and time between start of treatment and progression of disease.
- Treatment safety [ Time Frame: Three years ]Total number of adverse events, type of events and grade
- Number of participant without tumor activity [ Time Frame: Three years ]It will be measured following RANO guidelines: progression-free survival, progression-free survival at 6 month after the end of treatment and response rate
- Overall survival [ Time Frame: Three years ]Time between start of treatment and death
- Corticosteroids dose [ Time Frame: 6 months ]Number of patients that reported with modifications on corticosteroids dose
- Neurological status [ Time Frame: 6 months ]Comparison of Barthel questionnaire and Minimental test scores between baseline and 6-months evaluation
- Participants with MGMT methylation [ Time Frame: Three years ]

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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
Contact: Federico Nepote | 0034 934 34 44 12 | investigacion@mfar.net | |
Contact: Verónica Roca | 0034 934 34 44 12 | investigacion@mfar.net |
Spain | |
Hospital Germans Trias i Pujol | Recruiting |
Badalona, Barcelona, Spain, 08916 | |
Contact: Ana Márquez, Pharmacist 0034 934 33 44 12 ana.marquez@mfar.net | |
Principal Investigator: Carmen Balañá, MD | |
Institut Català D'Oncologia L'Hospitalet (Ico) | Recruiting |
L'Hospitalet de Llobregat, Barcelona, Spain, 08908 | |
Contact: Ana Márquez, Pharmacist +34934344412 ana.marquez@mfar.net | |
Principal Investigator: Carles Mesia, MD | |
Hospital Universitario Fundación Alcorcón | Active, not recruiting |
Alcorcón, Madrid, Spain, 28922 | |
Hospital Son Espases | Recruiting |
Palma de Mallorca, Mallorca, Spain, 07010 | |
Contact: Ana Márquez, Pharmacist +34 934344412 ana.marquez@mfar.net | |
Principal Investigator: Jose Fuster, MD | |
Hospital Universitario Sant Joan de Reus | Recruiting |
Reus, Tarragona, Spain, 43204 | |
Contact: Ana Márquez, Pharmacist +34 934344412 ana.marquez@mfar.net | |
Principal Investigator: Sergio Peralta, MD | |
Consorcio Hospitalario Provincial de Castellón | Active, not recruiting |
Castelló, Valencia, Spain, 12002 | |
Hospital Del Mar | Active, not recruiting |
Barcelona, Spain, 08003 | |
Hospital de La Santa Creu I Sant Pau | Active, not recruiting |
Barcelona, Spain, 08025 | |
Hospital Clínic de Barcelona | Recruiting |
Barcelona, Spain, 08036 | |
Contact: Ana Márquez, Pharmacist +34 934344412 ana.marquez@mfar.net | |
Principal Investigator: Estela Pineda, MD | |
Hospital General de Ciudad Real | Active, not recruiting |
Ciudad Real, Spain, 13005 | |
Hospital Dr. Josep Trueta de Girona | Recruiting |
Girona, Spain, 17007 | |
Contact: Ana Márquez, Pharmacist +34 934344412 ana.marquez@mfar.net | |
Principal Investigator: Sonia del Barco, MD | |
Hospital Arnau de Vilanova | Active, not recruiting |
Lleida, Spain, 25198 | |
Hospital Universitario Lucus Augusti | Recruiting |
Lugo, Spain, 27003 | |
Contact: Ana Márquez, Pharmacist +34 934344412 ana.marquez@mfar.net | |
Principal Investigator: Marta Covela, MD | |
Hospital Ramón Y Cajal | Recruiting |
Madrid, Spain, 28034 | |
Contact: Ana Márquez, Pharmacist +34934344412 ana.marquez@mfar.net | |
Principal Investigator: M Angeles Vaz Salgado, MD | |
Hospital Clínico San Carlos | Active, not recruiting |
Madrid, Spain, 28040 | |
Hospital Universitario 12 de Octubre | Active, not recruiting |
Madrid, Spain, 28041 | |
Hospital Clínico Universitario de Salamanca | Recruiting |
Salamanca, Spain, 37007 | |
Contact: Ana Márquez, Pharmacist +34 934344412 ana.marquez@mfar.net | |
Principal Investigator: Luis Miguel Navarro, MD | |
Hospital Universitario Virgen del Rocío | Recruiting |
Sevilla, Spain, 41013 | |
Contact: Ana Márquez, Pharmacist +34 934344412 ana.marquez@mfar.net | |
Principal Investigator: Begoña Pérez, MD | |
Consorcio Hospital General Universitario de Valencia | Recruiting |
Valencia, Spain, 46014 | |
Contact: Ana Márquez, Pharmacist +34 934344412 ana.marquez@mfar.net | |
Principal Investigator: Alfonso Berrocal, MD | |
Hospital Universitario Miguel Servet | Recruiting |
Zaragoza, Spain, 50009 | |
Contact: Ana Márquez, Pharmacist +34 934344412 ana.marquez@mfar.net | |
Principal Investigator: Ana Herrero, MD |
Study Chair: | Carmen Balañá, MD | Hospital Germnas Trias i Pujol- ICO Badalona | |
Study Chair: | Mª Ángeles Vaz, MD | Hospital Universitario Ramon y Cajal |
Responsible Party: | Grupo Español de Investigación en Neurooncología |
ClinicalTrials.gov Identifier: | NCT02209948 History of Changes |
Other Study ID Numbers: |
GEINO 14-01 2014-000838-39 ( EudraCT Number ) |
First Posted: | August 6, 2014 Key Record Dates |
Last Update Posted: | August 3, 2018 |
Last Verified: | August 2018 |
Additional relevant MeSH terms:
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 Dacarbazine Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |