Evidence map›Paper›PMID 29557060›Full record

Trial reportJournal of neuro-oncology2018

JCOG0911 INTEGRA study: a randomized screening phase II trial of interferonβ plus temozolomide in comparison with temozolomide alone for newly diagnosed glioblastoma.

Toshihiko Wakabayashi, Atsushi Natsume, Junki Mizusawa, Hiroshi Katayama, Haruhiko Fukuda, Minako Sumi, Ryo Nishikawa, Yoshitaka Narita, Yoshihiro Muragaki, Takashi Maruyama and 33 more

Abstract readClinical Trial, Phase IIComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of neuro-oncology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 44 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed, 6 pooled it
–field-weighted citation impact
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

44 citing papers in PubMed, 6 syntheses or guidelines pooled it.

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  7. Image-based Re-evaluation of the JCOG0911 Study Focusing on Tumor Volume and Survival, Disease Progression Diagnosis, and Radiomic Prognostication for Newly Diagnosed Glioblastoma.Magnetic resonance in medical sciences : MRMS : an official journal of Japan Society of Magnetic Resonance in Medicine · 2025
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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

43 authors.

Toshihiko WakabayashiDepartment of Neurosurgery, Nagoya University Graduate School of Medicine, Nagoya, Japan.
Atsushi NatsumeDepartment of Neurosurgery, Nagoya University Graduate School of Medicine, Nagoya, Japan. anatsume@med.nagoya-u.ac.jp.ORCID http://orcid.org/0000-0002-9113-0470
Junki MizusawaJCOG (Japan Clinical Oncology Group) Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.
Hiroshi KatayamaJCOG (Japan Clinical Oncology Group) Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.
Haruhiko FukudaJCOG (Japan Clinical Oncology Group) Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.
Minako SumiRadiation Oncology Department, Cancer Institute Hospital, Tokyo, Japan.
Ryo NishikawaDepartment of Neuro-Oncology/Neurosurgery, Saitama Medical University International Medical Center, Saitama, Japan.
Yoshitaka NaritaDepartment of Neurosurgery and Neuro-Oncology, National Cancer Center Hospital, Tokyo, Japan.
Yoshihiro MuragakiDepartment of Neurosurgery, Tokyo Women's Medical University, Tokyo, Japan.
Takashi MaruyamaDepartment of Neurosurgery, Tokyo Women's Medical University, Tokyo, Japan.
Tamio ItoDepartment of Neurosurgery, Nakamura Memorial Hospital, Sapporo, Japan.
Takaaki BeppuDepartment of Neurosurgery, Iwate Medical University, Morioka, Japan.
Hideo NakamuraDepartment of Neurosurgery, Kumamoto University Graduate School of Medicine, Kumamoto, Japan.
Takamasa KayamaDepartment of Neurosurgery, Yamagata University Graduate School of Medicine, Yamagata, Japan.
Shinya SatoDepartment of Neurosurgery, Yamagata University Graduate School of Medicine, Yamagata, Japan.
Motoo NaganeDepartment of Neurosurgery, Kyorin University Faculty of Medicine, Mitaka, Japan.
Kazuhiko MishimaDepartment of Neuro-Oncology/Neurosurgery, Saitama Medical University International Medical Center, Saitama, Japan.
Yoko NakasuDepartment of Neurosurgery, Shizuoka Cancer Center, Shizuoka, Japan.
Kaoru KurisuDepartment of Neurosurgery, Hiroshima University, Graduate School of Biomedical and Health Sciences, Hiroshima, Japan.
Fumiyuki YamasakiDepartment of Neurosurgery, Hiroshima University, Graduate School of Biomedical and Health Sciences, Hiroshima, Japan.
Kazuhiko SugiyamaDepartment of Clinical Oncology & Neuro-oncology Program, Hiroshima University Hospital, Hiroshima, Japan.
Takanori OnishiDepartment of Neurosurgery, Ehime University Graduate School of Medicine, Ehime, Japan.
Yasuo IwadateDepartment of Neurosurgery, Chiba University Graduate School of Medicine, Chiba, Japan.
Mizuhiko TerasakiDepartment of Neurosurgery, Kurume University Graduate School of Medicine, Kurume, Japan.
Hiroyuki KobayashiDepartment of Neurosurgery, Hokkaido University Graduate School of Medicine, Sapporo, Japan.
Akira MatsumuraDepartment of Neurosurgery, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.
Eiichi IshikawaDepartment of Neurosurgery, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.
Hikaru SasakiDepartment of Neurosurgery, Keio University School of Medicine, Tokyo, Japan.
Akitake MukasaDepartment of Neurosurgery, The University of Tokyo Hospital, Tokyo, Japan.
Takayuki MatsuoDepartment of Neurosurgery, Nagasaki University Graduate School of Medicine, Nagasaki, Japan.
Hirofumi HiranoDepartment of Neurosurgery, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, Japan.
Toshihiro KumabeDepartment of Neurosurgery, Tohoku University Graduate School of Medicine, Sendai, Japan.
Nobusada ShinouraDepartment of Neurosurgery, Tokyo Metropolitan Cancer and Infectious Disease Center Komagome Hospital, Tokyo, Japan.
Naoya HashimotoDepartment of Neurosurgery, Osaka University Graduate School of Medicine, Suita, Japan.
Tomokazu AokiDepartment of Neurosurgery, Kitano Hospital, Osaka, Japan.
Akio AsaiDepartment of Neurosurgery, Kansai Medical University, Osaka, Japan.
Tatsuya AbeDepartment of Neurosurgery, Oita University Faculty of Medicine, Yufu, Japan.
Atsuo YoshinoDepartment of Neurological Surgery, Nihon University Graduate School of Medicine, Tokyo, Japan.
Yoshiki ArakawaDepartment of Neurosurgery, Kyoto University Graduate School of Medicine, Kyoto, Japan.
Kenichiro AsanoDepartment of Neurosurgery, Hirosaki University Graduate School of Medicine, Hirosaki, Japan.
Koji YoshimotoDepartment of Neurosurgery, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Soichiro ShibuiDepartment of Neurosurgery and Neuro-Oncology, National Cancer Center Hospital, Tokyo, Japan.
Members of Japan Clinical Oncology Group Brain Tumor Study Group (JCOG-BTSG)

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThis study explored the superiority of temozolomide (TMZ) + interferonβ (IFNβ) to standard TMZ as treatment for newly diagnosed glioblastoma (GBM) via randomized phase II screening design. EXPERIMENTAL

designEligibility criteria included histologically proven GBM, with 50% of the tumor located in supratentorial areas, without involvement of the optic, olfactory nerves, and pituitary gland and without multiple lesions and dissemination. Patients in the TMZ + radiotherapy (RT) arm received RT (2.0 Gy/fr/day, 30 fr) with TMZ (75 mg/m

resultsBetween Apr 2010 and Jan 2012, 122 patients were randomized. The median OS with TMZ + RT and TMZ + IFNβ + RT was 20.3 and 24.0 months (HR 1.00, 95% CI 0.65-1.55; one-sided log rank P = 0.51). The median progression-free survival times were 10.1 and 8.5 months (HR 1.25, 95% CI 0.85-1.84). The incidence of neutropenia with the TMZ + RT and the TMZ + IFNβ + RT (grade 3-4, CTCAE version 3.0) was 12.7 versus 20.7% during concomitant period and was 3.6 versus 9.3% during maintenance period. The incidence of lymphopenia was 54.0 versus 63.8% and 34.5 versus 41.9%.

conclusionsTMZ + IFNβ + RT is not considered as a candidate for the following phase III trial, and TMZ + RT remained to be a most promising treatment. This trial was registered with the UMIN Clinical Trials Registry: UMIN000003466.

Indexed as

Administration, IntravenousAdultAgedAntineoplastic AgentsBrain NeoplasmsChemoradiotherapyFemaleGlioblastomaHumansInterferon-betaMaleMiddle AgedSurvival AnalysisTemozolomideTreatment OutcomeYoung AdultAntineoplastic AgentsInterferon-betaTemozolomideGlioblastomaInterferon-betaMGMTRCTTemozolomide

Identifiers

PMID29557060
PMCPMC5999164

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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.