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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 : Completed
First Posted : August 6, 2014
Last Update Posted : December 5, 2019
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)
Actual 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 : August 22, 2014
Actual Primary Completion Date : June 2019
Actual Study Completion Date : June 14, 2019

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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


Locations
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Sponsors and Collaborators
Grupo Español de Investigación en Neurooncología
Investigators
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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
More Information
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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
Last Update Posted: December 5, 2019
Last Verified: December 2019
Additional relevant MeSH terms:
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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