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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
Sponsor:
Information provided by (Responsible Party):
Grupo Español de Investigación en Neurooncología

Study Description
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Brief Summary:
The purpose of this study is to show if prolonging treatment with temozolomide to 12 cycles improve progression-free survival in patients with glioblastoma included in this study, randomized according to o6-methylguanine-DNA-methyltransferase (MGMT) methylation status and residual disease or not, to receive an additional 6 cycles of temozolomide.

Condition or disease Intervention/treatment Phase
Glioblastoma Drug: Temozolomide Phase 2

Study Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Temozolomide
Those patients will take 6 additional Temozolomide cycles
 Drug: Temozolomide
No Intervention: Without treatment


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Treatment safety [ Time Frame: Three years ]
    Total number of adverse events, type of events and grade

  2. 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

  3. Overall survival [ Time Frame: Three years ]
    Time between start of treatment and death

  4. Corticosteroids dose [ Time Frame: 6 months ]
    Number of patients that reported with modifications on corticosteroids dose

  5. Neurological status [ Time Frame: 6 months ]
    Comparison of Barthel questionnaire and Minimental test scores between baseline and 6-months evaluation

  6. Participants with MGMT methylation [ Time Frame: Three years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Ability to understand and sign the informed consent document .
  2. Age greater than or equal 18.
  3. 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.
  4. 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 ).
  5. Stable dose of dexamethasone in the inclusion never above corticoids dose received in cycle 6 of the adjuvant .
  6. Index greater than or equal 60 % Karnofsky.
  7. All patients must show no progression of disease in a brain nuclear magnetic resonance (NMR) as defined in RANO established criteria before randomization .
  8. 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).
  9. 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.
  10. Creatinine <1.5 times the upper limit of normal (ULN) of the laboratory performing the analysis.
  11. 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 .
  12. Effective contraceptive method in patients and their partners.

Exclusion Criteria:

  1. Less than 5 years of any previous invasive neoplasia. In situ cervical carcinoma or basal cell skin carcinoma accepted.
  2. Concomitant treatment with other investigational agents (other concomitant bevacizumab) .
  3. 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.
  4. Presence of any psychiatric or cognitive disorder that limits understanding or written informed consent and / or impair compliance with the requirements of this protocol.
  5. Concurrent disease that prevents the continuation of temozolomide treatment.
  6. Presence of leptomeningeal dissemination.
  7. Pregnant or breastfeeding.
  8. Positive patients receiving combination antiretroviral therapy in HIV
Contacts and Locations
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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


Contacts
Contact: Federico Nepote 0034 934 34 44 12 investigacion@mfar.net
Contact: Verónica Roca 0034 934 34 44 12 investigacion@mfar.net

Locations
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         
Sponsors and Collaborators
Grupo Español de Investigación en Neurooncología
Investigators
Study Chair: Carmen Balañá, MD Hospital Germnas Trias i Pujol- ICO Badalona
Study Chair: Mª Ángeles Vaz, MD Hospital Universitario Ramon y Cajal
More Information
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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