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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

Tracking Information
First Submitted Date  ICMJE August 4, 2014
First Posted Date  ICMJE August 6, 2014
Last Update Posted Date December 5, 2019
Actual Study Start Date  ICMJE August 22, 2014
Actual Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 14, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 5, 2014)
Progression free survival at 6 month [ Time Frame: 6 month ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2018)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 5, 2014)
  • Number of Adverse Events [ Time Frame: Three years ]
    Total number of adverse 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
  • Number of alive patients [ Time Frame: Three years ]
  • Corticosteroids dose [ Time Frame: 6 months ]
    Number of patients that have changed the use of corticosteroids
  • Barthel questionnaire and Minimental test [ Time Frame: 6 months ]
    Changes in neurological status
  • Participants with MGMT methylation [ Time Frame: Three years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Temozolomide 12 Cycles Versus 6 Cycles of Standard First-line Treatment in Patients With Glioblastoma.
Official Title  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Glioblastoma
Intervention  ICMJE Drug: Temozolomide
Study Arms  ICMJE
  • Experimental: Temozolomide
    Those patients will take 6 additional Temozolomide cycles
    Intervention: Drug: Temozolomide
  • No Intervention: Without treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 5, 2014)
160
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 14, 2019
Actual Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02209948
Other Study ID Numbers  ICMJE GEINO 14-01
2014-000838-39 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Grupo Español de Investigación en Neurooncología
Study Sponsor  ICMJE Grupo Español de Investigación en Neurooncología
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Grupo Español de Investigación en Neurooncología
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP