GlioblastomaPhase 2NCT02209948
Temozolomide 12 Cycles Versus 6 Cycles of Standard First-line Treatment in Patients With Glioblastoma.
A Phase 2 study testing Temozolomide in people with Glioblastoma, run by Grupo Español de Investigación en Neurooncología at 20 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Temozolomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 20 sitesSpain
- Study dates
- 22 Aug 2014to 14 Jun 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 12Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Spain20 sites
Hospital Universitario Fundación Alcorcón
Alcorcón, Madrid, 28922
Hospital Universitari Germans Trias i Pujol/ICO Badalona
Badalona, Barcelona, 08916
Hospital del Mar
Barcelona, 08003
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Hospital Clínic de Barcelona
Barcelona, 08036
Consorcio Hospitalario Provincial de Castellón
Castellon, Valencia, 12002
Hospital General de Ciudad Real
Ciudad Real, 13005
Hospital Dr. Josep Trueta de Girona
Girona, 17007
Institut Català d'Oncologia L'Hospitalet
L'Hospitalet de Llobregat, Barcelona, 08908
Hospital Arnau de Vilanova
Lleida, 25198
Hospital Universitario Lucus Augusti
Lugo, 27003
Hospital Universitario Ramón y Cajal
Madrid, 28034
Hospital Universitario Clínico San Carlos
Madrid, 28040
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Son Espases
Palma de Mallorca, Mallorca, 07010
Hospital Universitario Sant Joan de Reus
Reus, Tarragona, 43204
Hospital Clínico Universitario de Salamanca
Salamanca, 37007
Hospital Universitario Virgen del Rocío
Seville, 41013
Consorcio Hospital General Universitario de Valencia
Valencia, 46014
Hospital Universitario Miguel Servet
Zaragoza, 50009
About this study
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.
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.
- Conditions
- Glioblastoma
- Being tested
- Temozolomide
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TemozolomideDrug
| Study group | Role | What they receive |
|---|---|---|
| Temozolomide | Experimental | Those patients will take 6 additional Temozolomide cycles Receives: Drug: Temozolomide |
| Without treatment | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 month
Secondary outcomes (6)
Number of Participants With Adverse Effects
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.
Measured: Through the whole study. 4 years
Progresion Free Survival Median Values
It will be measured following Response assessment in neuro-oncology (RANO) guidelines: progression-free survival
Measured: Through the whole study. 4 years. The median follow up for each patient was 33.4 months
Overall Survival
Time between start of treatment and death
Measured: 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
Median Progression Free Survival depending on treatment arm in patients with MGMT methylation
Measured: 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
Median OS depending on treatment arm in patients with methylated MGMT
Measured: Through the whole study. 4 years. The median follow up for each patient was 33.4 months
Translational Sub-study - Biomarkers: mutS Homolog 6 (MSH6) Immunoreactivity
partial immunoreactivity of MSH6 in patients by treatment arm. Tumor samples were stained by immuno-histochemical techniques.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2014 (estimated)
- Study start22 Aug 2014
- Primary completionJun 2019
- Study completion14 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grupo Español de Investigación en Neurooncología
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carmen Balañá, M.D., Study chair, Hospital Germans Trias i Pujol - ICO BadalonaMª Ángeles Vaz, M.D., Study chair, Hospital Universitario Ramon y Cajal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02209948
- Sponsor's protocol ID
- GEINO 14-01
- Other IDs
- 2014-000838-39, 2014
- Status last verified
- Dec 2020
- First submitted
- 4 Aug 2014
- Last updated
- 12 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 32328662
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02209948
- Acronym / sponsor ID
- GEINO 14-01
- Conditions
- Glioblastoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Grupo Español de Investigación en NeurooncologíaUniversity, hospital or other
- Study start
- 22 Aug 2014 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- 14 Jun 2019 (actual)
- First posted
- 6 Aug 2014 (estimated)
- Results
- Posted 12 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Temozolomide | Experimental | Drug: TemozolomideThose patients will take 6 additional Temozolomide cycles |
| Without treatment | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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 .
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Temozolomide | Drug | Temozolomide |
Primary outcome
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.
6 secondary outcomes
Number of Participants With Adverse Effects
Time frame: Through the whole study. 4 years
Progresion Free Survival Median Values
Time frame: Through the whole study. 4 years. The median follow up for each patient was 33.4 months
Overall Survival
Time frame: 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
Time frame: 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
Time frame: Through the whole study. 4 years. The median follow up for each patient was 33.4 months
Translational Sub-study - Biomarkers: mutS Homolog 6 (MSH6) Immunoreactivity
Time frame: baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32328662Balana 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carmen Balañá, M.D. study chair
Hospital Germans Trias i Pujol - ICO Badalona
Mª Ángeles Vaz, M.D. study chair
Hospital Universitario Ramon y Cajal
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Temozolomide in people with Glioblastoma, run by Grupo Español de Investigación en Neurooncología at 20 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival at 6 Month (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02209948, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2021; AzTrials last refreshed its copy on 7 Nov 2026.