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

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.

Timeline

Start

2014-08-22

Primary completion

2019-06

Completion

2019-06-14

Outcome

Missed primary endpoint

paper There were no differences in 6-month PFS (control 55.7%; experimental 61.3%), PFS, or OS between arms. PMID 32328662 ↗

paper Continuing temozolomide after 6 adjuvant cycles is associated with greater toxicity but confers no additional benefit in 6-month PFS. PMID 32328662 ↗

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Temozolomide	Small molecule	—	—

Indications