Temozolomide 12 Cycles Versus 6 Cycles of Standard First-line Treatment in Patients With Glioblastoma.
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.
2 other identifiers
interventional
166
1 country
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2014
Longer than P75 for phase_2
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 4, 2014
CompletedFirst Posted
Study publicly available on registry
August 6, 2014
CompletedStudy Start
First participant enrolled
August 22, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 14, 2019
CompletedResults Posted
Study results publicly available
January 12, 2021
CompletedJanuary 12, 2021
December 1, 2020
4.8 years
August 4, 2014
October 20, 2020
December 17, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Progression Free Survival at 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.
6 month
Secondary Outcomes (6)
Number of Participants With Adverse Effects
Through the whole study. 4 years
Progresion Free Survival Median Values
Through the whole study. 4 years. The median follow up for each patient was 33.4 months
Overall Survival
Through the whole study. 4 years. The median follow up for each patient was 33.4 months
Median Progression-free Survival (PFS) by Arm and MGMT Methylation Status
Through the whole study. 4 years. The median follow up for each patient was 33.4 months
Median Overall Survival (OS) by Arm and MGMT Methylation Status
Through the whole study. 4 years. The median follow up for each patient was 33.4 months
- +1 more secondary outcomes
Study Arms (2)
Temozolomide
EXPERIMENTALThose patients will take 6 additional Temozolomide cycles
Without treatment
NO INTERVENTIONInterventions
Eligibility Criteria
You may qualify if:
- 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 ).
- 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 .
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Hospital Universitari Germans Trias i Pujol/ICO Badalona
Badalona, Barcelona, 08916, Spain
Institut Català d'Oncologia L'Hospitalet
L'Hospitalet de Llobregat, Barcelona, 08908, Spain
Hospital Universitario Fundación Alcorcón
Alcorcón, Madrid, 28922, Spain
Hospital Son Espases
Palma de Mallorca, Mallorca, 07010, Spain
Hospital Universitario Sant Joan de Reus
Reus, Tarragona, 43204, Spain
Consorcio Hospitalario Provincial de Castellón
Castellon, Valencia, 12002, Spain
Hospital del Mar
Barcelona, 08003, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025, Spain
Hospital Clínic de Barcelona
Barcelona, 08036, Spain
Hospital General de Ciudad Real
Ciudad Real, 13005, Spain
Hospital Dr. Josep Trueta de Girona
Girona, 17007, Spain
Hospital Arnau de Vilanova
Lleida, 25198, Spain
Hospital Universitario Lucus Augusti
Lugo, 27003, Spain
Hospital Universitario Ramón y Cajal
Madrid, 28034, Spain
Hospital Universitario Clínico San Carlos
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Clínico Universitario de Salamanca
Salamanca, 37007, Spain
Hospital Universitario Virgen del Rocío
Seville, 41013, Spain
Consorcio Hospital General Universitario de Valencia
Valencia, 46014, Spain
Hospital Universitario Miguel Servet
Zaragoza, 50009, Spain
Related Publications (1)
Balana C, Vaz MA, Manuel Sepulveda J, Mesia C, Del Barco S, Pineda E, Munoz-Langa J, Estival A, de Las Penas R, Fuster J, Girones R, Navarro LM, Gil-Gil M, Alonso M, Herrero A, Peralta S, Olier C, Perez-Segura P, Covela M, Martinez-Garcia M, Berrocal A, Gallego O, Luque R, Perez-Martin FJ, Esteve A, Munne N, Domenech M, Villa S, Sanz C, Carrato C. A phase II randomized, multicenter, open-label trial of continuing adjuvant temozolomide beyond 6 cycles in patients with glioblastoma (GEINO 14-01). Neuro Oncol. 2020 Dec 18;22(12):1851-1861. doi: 10.1093/neuonc/noaa107.
PMID: 32328662DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Our trial was not powered to detect significant differences in PFS or OS. To do so, we would have had to know the survival distribution for patients who complete the standard six cycles without progression, but this information was not available
Results Point of Contact
- Title
- Pau Doñate
- Organization
- MFAR Clinical Research
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2014
First Posted
August 6, 2014
Study Start
August 22, 2014
Primary Completion
June 1, 2019
Study Completion
June 14, 2019
Last Updated
January 12, 2021
Results First Posted
January 12, 2021
Record last verified: 2020-12