Status:
COMPLETED
Temozolomide 12 Cycles Versus 6 Cycles of Standard First-line Treatment in Patients With Glioblastoma.
Lead Sponsor:
Grupo Español de Investigación en Neurooncología
Conditions:
Glioblastoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- Ability to understand and sign the informed consent document .
- Age greater than or equal 18.
- 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.
- 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 ).
- Stable dose of dexamethasone in the inclusion never above corticoids dose received in cycle 6 of the adjuvant .
- Index greater than or equal 60 % Karnofsky.
- All patients must show no progression of disease in a brain nuclear magnetic resonance (NMR) as defined in RANO established criteria before randomization .
- 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).
- 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.
- Creatinine \<1.5 times the upper limit of normal (ULN) of the laboratory performing the analysis.
- 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 .
- Effective contraceptive method in patients and their partners.
Exclusion
- Less than 5 years of any previous invasive neoplasia. In situ cervical carcinoma or basal cell skin carcinoma accepted.
- Concomitant treatment with other investigational agents (other concomitant bevacizumab) .
- 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.
- Presence of any psychiatric or cognitive disorder that limits understanding or written informed consent and / or impair compliance with the requirements of this protocol.
- Concurrent disease that prevents the continuation of temozolomide treatment.
- Presence of leptomeningeal dissemination.
- Pregnant or breastfeeding.
- Positive patients receiving combination antiretroviral therapy in HIV
Key Trial Info
Start Date :
August 22 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 14 2019
Estimated Enrollment :
166 Patients enrolled
Trial Details
Trial ID
NCT02209948
Start Date
August 22 2014
End Date
June 14 2019
Last Update
January 12 2021
Active Locations (20)
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1
Hospital Universitari Germans Trias i Pujol/ICO Badalona
Badalona, Barcelona, Spain, 08916
2
Institut Català d'Oncologia L'Hospitalet
L'Hospitalet de Llobregat, Barcelona, Spain, 08908
3
Hospital Universitario Fundación Alcorcón
Alcorcón, Madrid, Spain, 28922
4
Hospital Son Espases
Palma de Mallorca, Mallorca, Spain, 07010