ClinicalTrials.gov

History of Changes for Study: NCT02209948
Temozolomide 12 Cycles Versus 6 Cycles of Standard First-line Treatment in Patients With Glioblastoma.
Latest version (submitted December 17, 2020) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 August 5, 2014 None (earliest Version on record)
2 September 5, 2014 Recruitment Status, Study Status, Contacts/Locations and Study Design
3 October 13, 2014 Contacts/Locations and Study Status
4 December 19, 2014 Contacts/Locations and Study Status
5 March 10, 2015 Contacts/Locations and Study Status
6 May 4, 2015 Contacts/Locations and Study Status
7 August 25, 2015 Contacts/Locations and Study Status
8 August 10, 2016 Study Status
9 March 14, 2018 Contacts/Locations, Study Status and Outcome Measures
10 August 2, 2018 Study Status
11 May 30, 2019 Recruitment Status, Study Status and Contacts/Locations
12 December 4, 2019 Recruitment Status, Study Status, Contacts/Locations and Study Design
Show
Results Submission Events
13 December 17, 2020 Outcome Measures, Study Status, Document Section, Results and Study Design
Comparison Format:

Scroll up to access the controls

Study NCT02209948
Submitted Date:  May 4, 2015 (v6)

Open or close this module Study Identification
Unique Protocol ID: GEINO 14-01
Brief Title: Temozolomide 12 Cycles Versus 6 Cycles of Standard First-line Treatment in Patients With Glioblastoma.
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.
Secondary IDs: 2014-000838-39 [EudraCT Number]
Open or close this module Study Status
Record Verification: September 2014
Overall Status: Recruiting
Study Start: August 2014
Primary Completion: July 2017 [Anticipated]
Study Completion: July 2017 [Anticipated]
First Submitted: August 4, 2014
First Submitted that
Met QC Criteria:
August 5, 2014
First Posted: August 6, 2014 [Estimate]
Last Update Submitted that
Met QC Criteria:
May 4, 2015
Last Update Posted: May 5, 2015 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Grupo Español de Investigación en Neurooncología
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: Glioblastoma
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 160 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Temozolomide
Those patients will take 6 additional Temozolomide cycles
Drug: Temozolomide
No Intervention: Without treatment
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Progression free survival at 6 month
[ Time Frame: 6 month ]

Secondary Outcome Measures:
1. Number of Adverse Events
[ Time Frame: Three years ]

Total number of adverse 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. Number of alive patients
[ Time Frame: Three years ]

4. Corticosteroids dose
[ Time Frame: 6 months ]

Number of patients that have changed the use of corticosteroids
5. Barthel questionnaire and Minimental test
[ Time Frame: 6 months ]

Changes in neurological status
6. Participants with MGMT methylation
[ Time Frame: Three years ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Central Contact Person: Ana Márquez, Graduate
Telephone: 0034 934 34 44 12 Ext. 114
Email: ana.marquez@mfar.net
Study Officials: Carmen Balañá, MD
Study Chair
Hospital Germnas Trias i Pujol- ICO Badalona
Mª Ángeles Vaz, MD
Study Chair
Hospital Universitario Ramon y Cajal
Locations: Spain
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:Contact: Ana Márquez, Pharmacist +34 934344412 ana.marquez@mfar.net
Contact:Principal Investigator: Estela Pineda, MD
Consorcio Hospitalario Provincial de Castellón
[Active, not recruiting]
Castellón, Spain, 12002
Hospital General de Ciudad Real
[Active, not recruiting]
Ciudad Real, Spain, 13005
Hospital Dr. Josep Trueta de Girona
[Recruiting]
Girona, Spain, 17007
Contact:Contact: Ana Márquez, Pharmacist +34 934344412 ana.marquez@mfar.net
Contact:Principal Investigator: Sonia del Barco, MD
Hospital Arnau de Vilanova
[Active, not recruiting]
Lleida, Spain, 25198
Hospital Universitario Lucus Augusti
[Active, not recruiting]
Lugo, Spain, 27003
Hospital Ramón Y Cajal
[Recruiting]
Madrid, Spain, 28034
Contact:Contact: Ana Márquez, Pharmacist +34934344412 ana.marquez@mfar.net
Contact: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:Contact: Ana Márquez, Pharmacist +34 934344412 ana.marquez@mfar.net
Contact:Principal Investigator: Luis Miguel Navarro, MD
Hospital Universitario Virgen del Rocío
[Active, not recruiting]
Sevilla, Spain, 41013
Consorcio Hospital General Universitario de Valencia
[Recruiting]
Valencia, Spain, 46014
Contact:Contact: Ana Márquez, Pharmacist +34 934344412 ana.marquez@mfar.net
Contact:Principal Investigator: Alfonso Berrocal, MD
Hospital Universitario Miguel Servet
[Recruiting]
Zaragoza, Spain, 50009
Contact:Contact: Ana Márquez, Pharmacist +34 934344412 ana.marquez@mfar.net
Contact:Principal Investigator: Ana Herrero, MD
Spain, Barcelona
Hospital Germans Trias i Pujol
[Recruiting]
Badalona, Barcelona, Spain, 08916
Contact:Contact: Ana Márquez, Pharmacist 0034 934 33 44 12 ana.marquez@mfar.net
Contact:Principal Investigator: Carmen Balañá, MD
Institut Català D'Oncologia L'Hospitalet (Ico)
[Recruiting]
L'Hospitalet de Llobregat, Barcelona, Spain, 08908
Contact:Contact: Ana Márquez, Pharmacist +34934344412 ana.marquez@mfar.net
Contact:Principal Investigator: Carles Mesia, MD
Spain, Madrid
Hospital Universitario Fundación Alcorcón
[Active, not recruiting]
Alcorcón, Madrid, Spain, 28922
Spain, Mallorca
Hospital Son Espases
[Recruiting]
Palma de Mallorca, Mallorca, Spain, 07010
Contact:Contact: Ana Márquez, Pharmacist +34 934344412 ana.marquez@mfar.net
Contact:Principal Investigator: Jose Fuster, MD
Spain, Tarragona
Hospital Universitario Sant Joan de Reus
[Recruiting]
Reus, Tarragona, Spain, 43204
Contact:Contact: Ana Márquez, Pharmacist +34 934344412 ana.marquez@mfar.net
Contact:Principal Investigator: Sergio Peralta, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services