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

NCT ID: NCT02209948

Last Updated: 2021-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 166 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-22
• Study Completion Date: 2019-06-14

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.

Conditions

Glioblastoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Temozolomide

Those patients will take 6 additional Temozolomide cycles

Group Type: EXPERIMENTAL

Temozolomide

Intervention Type: DRUG

Without treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Temozolomide

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Grupo Español de Investigación en Neurooncología

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carmen Balañá, M.D.

Role: STUDY_CHAIR

Hospital Germans Trias i Pujol - ICO Badalona

Mª Ángeles Vaz, M.D.

Role: STUDY_CHAIR

Hospital Universitario Ramon y Cajal

Locations

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Hospital Clínic de Barcelona

Barcelona, , Spain

Hospital General de Ciudad Real

Ciudad Real, , Spain

Hospital Dr. Josep Trueta de Girona

Girona, , Spain

Hospital Arnau de Vilanova

Lleida, , Spain

Hospital Universitario Lucus Augusti

Lugo, , Spain

Hospital Universitario Ramón y Cajal

Madrid, , Spain

Hospital Universitario Clínico San Carlos

Madrid, , Spain

Hospital Universitario 12 de Octubre

Madrid, , Spain

Hospital Universitario Virgen del Rocío

Seville, , Spain

Hospital Clínico Universitario de Salamanca

Salamanca, , Spain

Hospital Universitari Germans Trias i Pujol/ICO Badalona

Badalona, Barcelona, Spain

Institut Català d'Oncologia L'Hospitalet

L'Hospitalet de Llobregat, Barcelona, Spain

Hospital Universitario Fundación Alcorcón

Alcorcón, Madrid, Spain

Hospital Son Espases

Palma de Mallorca, Mallorca, Spain

Hospital Universitario Sant Joan de Reus

Reus, Tarragona, Spain

Consorcio Hospitalario Provincial de Castellón

Castellon, Valencia, Spain

Hospital del Mar

Barcelona, , Spain

Consorcio Hospital General Universitario de Valencia

Valencia, , Spain

Hospital Universitario Miguel Servet

Zaragoza, , Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 32328662 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

2014-000838-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GEINO 14-01

Identifier Type: -

Identifier Source: org_study_id