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Temozolomide 12 Cycles Versus 6 Cycles of Standard First-line Treatment in Patients With Glioblastoma.

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02209948
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Grupo Español de Investigación en Neurooncología
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Carmen Balañá, M.D.Mª Ángeles Vaz, M.D.
Principal Investigator Affiliation Hospital Germans Trias i Pujol - ICO BadalonaHospital Universitario Ramon y Cajal
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Completed
Countries Spain
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioblastoma
Arms & Interventions

Arms

Experimental: Temozolomide

Those patients will take 6 additional Temozolomide cycles

No Intervention: Without treatment

Interventions

Drug: - Temozolomide

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Badalona, Barcelona, Spain

Status

Address

Hospital Universitari Germans Trias i Pujol/ICO Badalona

Badalona, Barcelona, 08916

Institut Català d'Oncologia L'Hospitalet, L'Hospitalet de Llobregat, Barcelona, Spain

Status

Address

Institut Català d'Oncologia L'Hospitalet

L'Hospitalet de Llobregat, Barcelona, 08908

Alcorcón, Madrid, Spain

Status

Address

Hospital Universitario Fundación Alcorcón

Alcorcón, Madrid, 28922

Hospital Son Espases, Palma de Mallorca, Mallorca, Spain

Status

Address

Hospital Son Espases

Palma de Mallorca, Mallorca, 07010

Hospital Universitario Sant Joan de Reus, Reus, Tarragona, Spain

Status

Address

Hospital Universitario Sant Joan de Reus

Reus, Tarragona, 43204

Castelló, Valencia, Spain

Status

Address

Consorcio Hospitalario Provincial de Castellón

Castelló, Valencia, 12002

Hospital del Mar, Barcelona, Spain

Status

Address

Hospital del Mar

Barcelona, , 08003

Hospital de la Santa Creu i Sant Pau, Barcelona, Spain

Status

Address

Hospital de la Santa Creu i Sant Pau

Barcelona, , 08025

Hospital Clínic de Barcelona, Barcelona, Spain

Status

Address

Hospital Clínic de Barcelona

Barcelona, , 08036

Hospital General de Ciudad Real, Ciudad Real, Spain

Status

Address

Hospital General de Ciudad Real

Ciudad Real, , 13005

Hospital Dr. Josep Trueta de Girona, Girona, Spain

Status

Address

Hospital Dr. Josep Trueta de Girona

Girona, , 17007

Hospital Arnau de Vilanova, Lleida, Spain

Status

Address

Hospital Arnau de Vilanova

Lleida, , 25198

Hospital Universitario Lucus Augusti, Lugo, Spain

Status

Address

Hospital Universitario Lucus Augusti

Lugo, , 27003

Hospital Universitario Ramón y Cajal, Madrid, Spain

Status

Address

Hospital Universitario Ramón y Cajal

Madrid, , 28034

Madrid, Spain

Status

Address

Hospital Universitario Clínico San Carlos

Madrid, , 28040

Hospital Universitario 12 de Octubre, Madrid, Spain

Status

Address

Hospital Universitario 12 de Octubre

Madrid, , 28041

Salamanca, Spain

Status

Address

Hospital Clínico Universitario de Salamanca

Salamanca, , 37007

Hospital Universitario Virgen del Rocío, Sevilla, Spain

Status

Address

Hospital Universitario Virgen del Rocío

Sevilla, , 41013

Valencia, Spain

Status

Address

Consorcio Hospital General Universitario de Valencia

Valencia, , 46014

Hospital Universitario Miguel Servet, Zaragoza, Spain

Status

Address

Hospital Universitario Miguel Servet

Zaragoza, , 50009