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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
Results First Posted : January 12, 2021
Last Update Posted : January 12, 2021
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 : 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

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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 ]

    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.



Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.


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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Information from the National Library of Medicine

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
  Study Documents (Full-Text)

Documents provided by Grupo Español de Investigación en Neurooncología:
Statistical Analysis Plan  [PDF] May 1, 2018
Study Protocol  [PDF] September 8, 2014

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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
Results First Posted: January 12, 2021
Last Update Posted: January 12, 2021
Last Verified: December 2020
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