Evidence map›Paper›PMID 37094899›Full record

ArticleBMJ open2023

Multidrug chemotherapy, whole-brain radiation and cytarabine therapy for primary central nervous system lymphoma in elderly patients with dose modification based on geriatric assessment: study protocol for a phase II, multicentre, non-randomised study.

Fumiyuki Yamasaki, Hirotaka Fudaba, Kenichiro Asano, Takashi Sasayama, Manabu Natsumeda, Taichi Shimabukuro, Kotaro Taguchi, Shinichiro Koizumi, Noriyuki Nakayama, Kentaro Fujii and 17 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.4field-weighted citation impact, top 37% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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 registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 2 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

27 authors at 13 institutions in 1 country.

Fumiyuki YamasakiDepartment of Neurosurgery, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan fyama@hiroshima-u.ac.jp kanimo@med.tottori-u.ac.jp.ORCID 0000-0003-0164-6295
Hirotaka FudabaDepartment of Neurosurgery, Oita University Faculty of Medicine, Yufu, Japan.
Kenichiro AsanoDepartment of Neurosurgery, Hirosaki University Graduate School of Medicine, Hirosaki, Japan.
Takashi SasayamaDepartment of Neurosurgery, Kobe University Graduate School of Medicine, Kobe, Japan.
Manabu NatsumedaDepartment of Neurosurgery, Brain Research Institute, Niigata University, Niigata, Japan.
Taichi ShimabukuroDepartment of Neurosurgery, Ube Industries Central Hospital, Ube, Japan.
Kotaro TaguchiDepartment of Radiology, National Hospital Organization Yamaguchi-Ube Medical Center, Ube, Japan.
Shinichiro KoizumiDepartment of Neurosurgery, Hamamatsu University School of Medicine, Hamamatsu, Japan.
Noriyuki NakayamaDepartment of Neurosurgery, Gifu University Graduate School of Medicine, Gifu, Japan.
Kentaro FujiiDepartment of Neurological Surgery, Okayama University Faculty of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.
Ikuno NishibuchiDepartment of Radiation Oncology, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.
Kazuhiko SugiyamaDepartment of Clinical Oncology and Neuro-Oncology Program, Hiroshima University Hospital, Hiroshima, Japan.
Kenji YoshidaDepartment of Radiation Oncology, Tottori University Hospital, Yonago, Japan.
Ushio YonezawaDepartment of Neurosurgery, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.
Momii YasutomoDepartment of Neurosurgery, Oita University Faculty of Medicine, Yufu, Japan.
Yukari KawasakiDepartment of Neurosurgery, Oita University Faculty of Medicine, Yufu, Japan.
Kiyohide KakutaDepartment of Neurosurgery, Hirosaki University Graduate School of Medicine, Hirosaki, Japan.
Kosuke KatayamaDepartment of Neurosurgery, Hirosaki University Graduate School of Medicine, Hirosaki, Japan.
Kazuhiro TanakaDepartment of Neurosurgery, Kobe University Graduate School of Medicine, Kobe, Japan.
Hiroaki NagashimaDepartment of Neurosurgery, Kobe University Graduate School of Medicine, Kobe, Japan.
Yoshihiro TsukamotoDepartment of Neurosurgery, Brain Research Institute, Niigata University, Niigata, Japan.
Makoto IdeguchiDepartment of Neurosurgery, Ube Industries Central Hospital, Ube, Japan.
Takafumi NishizakiDepartment of Neurosurgery, Ube Industries Central Hospital, Ube, Japan.
Kazuhiko KurozumiDepartment of Neurosurgery, Hamamatsu University School of Medicine, Hamamatsu, Japan.
Tomohiro HosoyaDepartment of Brain and Neurosciences, Division of Neurosurgery, Tottori University, Yonago, Japan.
Tomoyuki AkitaDepartment of Biostatistics, Clinical Research Center in Hiroshima, Hiroshima University Hospital, Hiroshima, Japan.
Atsushi KambeDepartment of Brain and Neurosciences, Division of Neurosurgery, Tottori University, Yonago, Japan fyama@hiroshima-u.ac.jp kanimo@med.tottori-u.ac.jp.
Hirosaki University · JPHiroshima University · JPKobe University · JPOita University · JPUbe (Japan) · JPHamamatsu University School of Medicine · JPHiroshima University Hospital · JPNiigata University · JPTottori University · JPGifu University · JPNational Sanyo Hospital · JPOkayama University · JPTottori University Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionMultidrug chemoimmunotherapy with rituximab, high-dose methotrexate, procarbazine and vincristine (R-MPV) is a standard therapy for younger patients with primary central nervous system lymphoma (PCNSL); however, prospective data regarding its use in elderly patients are lacking. This multi-institutional, non-randomised, phase II trial will assess the efficacy and safety of R-MPV and high-dose cytarabine (HD-AraC) for geriatric patients with newly diagnosed PCNSL. METHODS AND ANALYSIS: Forty-five elderly patients will be included. If R-MPV does not achieve complete response, the patients will undergo reduced-dose, whole-brain radiotherapy comprising 23.4 Gy/13 fractions, followed by local boost radiotherapy comprising 21.6 Gy/12 fractions. After achieving complete response using R-MPV with or without radiotherapy, the patients will undergo two courses of HD-AraC. All patients will undergo baseline geriatric 8 (G8) assessment before HD-AraC and after three, five and seven R-MPV courses. Patients with screening scores of ≥14 points that decrease to <14 points during subsequent treatment, or those with screening scores <14 points that decrease from the baseline during subsequent treatment are considered unfit for R-MPV/HD-AraC. The primary endpoint is overall survival, and the secondary endpoints are progression-free survival, treatment failure-free survival and frequency of adverse events. The results will guide a later phase III trial and provide information about the utility of a geriatric assessment for defining chemotherapy ineligibility. ETHICS AND DISSEMINATION: This study complies with the latest Declaration of Helsinki. Written informed consent will be obtained. All participants can quit the study without penalty or impact on treatment. The protocol for the study, statistical analysis plan and informed consent form have been approved by the Certified Review Board at Hiroshima University (CRB6180006) (approval number: CRB2018-0011). The study is ongoing within nine tertiary and two secondary hospitals in Japan. The findings of this trial will be disseminated through national and international presentations and peer-reviewed publications.

trial registrationjRCTs061180093.

Indexed as

Central Nervous System NeoplasmsLymphomaAgedAntineoplastic Combined Chemotherapy ProtocolsBrainCentral Nervous SystemClinical Trials, Phase II as TopicCytarabineHumansMethotrexateMulticenter Studies as TopicProspective StudiesRituximabTreatment OutcomeVincristineCytarabineMethotrexateRituximabVincristineClinical trialsGERIATRIC MEDICINELymphomaNeurological oncology

Identifiers

PMID37094899
PMCPMC10151848
OpenAlexW4366817559

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.