Trial reportJapanese journal of clinical oncology2026
A multicenter randomized phase II/III trial of salvage treatment for refractory primary central nervous system lymphoma using tirabrutinib: JCOG2314 (ReSTART).
Kota Kawabata, Fumiharu Ohka, Ryuta Saito, Tsuyoshi Onoe, Hideyuki Harada, Takashi Sasayama, Hideaki Yokoo, Yoshiki Arakawa, Junki Mizusawa, Noriko Mitome and 4 more
Abstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraphTrial report in Japanese journal of clinical oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
2 · The registryThe trial behind it
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4 · The recordCorrections and comments
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5 · Who and what moneyAuthors and funding
14 authors.
Kota KawabataJapan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan.ORCID 0009-0006-5057-7985 Fumiharu OhkaDepartment of Neurosurgery, Graduate School of Medicine, Nagoya University, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi 466-8550, Japan.ORCID 0000-0002-5569-5626 Ryuta SaitoDepartment of Neurosurgery, Graduate School of Medicine, Nagoya University, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi 466-8550, Japan.ORCID 0000-0002-2484-1360 Tsuyoshi OnoeRadiation and Proton Therapy Center, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777, Japan.
Hideyuki HaradaRadiation and Proton Therapy Center, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777, Japan.ORCID 0000-0001-6450-3027 Takashi SasayamaDepartment of Neurosurgery, Kobe University Graduate School of Medicine, 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo 650-0017, Japan.ORCID 0000-0002-5593-9045 Hideaki YokooDepartment of Human Pathology, Gunma University Graduate School of Medicine, 3-39-22 Showa-machi, Maebashi, Gunma 371-8511, Japan.
Yoshiki ArakawaDepartment of Neurosurgery, Kyoto University Graduate School of Medicine, 54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto 606-8507, Japan.ORCID 0000-0003-4626-4645 Junki MizusawaJapan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan.ORCID 0000-0001-8123-5298 Noriko MitomeJapan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan.ORCID 0009-0000-0082-9028 Keita SasakiJapan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan.ORCID 0009-0005-5100-3863 Haruhiko FukudaJapan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan.
Yoshitaka NaritaDepartment of Neurosurgery and Neuro-Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan.ORCID 0000-0003-4303-6006 Brain Tumor Study Group of the Japan Clinical Oncology Group
Funding
Japan Agency for Medical Research and Development JP25ck0106079National Cancer Center Research and Development Fund 2023-J-03National Cancer Center Research and Development Fund 2026-J-03
6 · The paper itselfAbstract
Primary central nervous system lymphoma (PCNSL) is an aggressive malignancy. Patients refractory to high-dose methotrexate-based induction therapy have an extremely poor prognosis. Although whole-brain radiotherapy (WBRT) is the standard salvage treatment and provides potent tumor control, early functional deterioration and late neurocognitive toxicity remain major concerns. A phase I/II trial on relapsed or refractory PCNSL demonstrated favorable efficacy and tolerability of tirabrutinib, a second-generation selective Bruton's tyrosine kinase inhibitor. Tirabrutinib's oral administration has enabled outpatient management. However, its clinical value for induction-refractory PCNSL remains uncertain. We designed a multicenter, randomized phase II/III trial (JCOG2314) to assess the non-inferiority of tirabrutinib to WBRT in overall survival and its potential to reduce functional deterioration and cognitive impairment. A total of 94 patients from 49 institutions will be enrolled over 4 years. The trial has been registered in the Japan Registry of Clinical Trials (study number: jRCT1031250645).
Indexed as
Central Nervous System NeoplasmsLymphomaProtein Kinase InhibitorsPyrimidinesSalvage TherapyCranial IrradiationFemaleHumansMaleProtein Kinase InhibitorsPyrimidinesHD-MTX-based induction therapyprimary central nervous system lymphomarefractory PCNSLtirabrutinibwhole-brain radiotherapy
Identifiers
PMID42315131
PMCPMC13556510
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