Evidence map›Paper›PMID 30139721›Full record

ArticleJMIR research protocols2018

Postoperative Bio-Chemoradiotherapy Using Cetuximab and Docetaxel in Patients With Cis-Platinum-Intolerant Core High-Risk Head and Neck Cancer: Protocol of a Phase 2 Nonrandomized Clinical Trial.

Goshi Nishimura, Hiromitsu Hatakeyama, Osamu Shiono, Masataka Taguri, Masanori Komatsu, Daisuke Sano, Naoko Sakuma, Kenichiro Yabuki, Yasuhiro Arai, Kunihiko Shibata and 3 more

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in JMIR research protocols, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.2field-weighted citation impact, top 49% 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

1 citing paper in PubMed, 3 citations in OpenAlex.

  1. 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

13 authors at 3 institutions in 1 country.

Goshi NishimuraDepartment of Otorhinolaryngology, Head and Neck Surgery, School of Medicine, Yokohama City University, Yokohama, Japan.ORCID http://orcid.org/0000-0002-9944-4474
Hiromitsu HatakeyamaDepartment of Otorhinolaryngology, Yokohama City University Medical Center, Yokohama, Japan.ORCID http://orcid.org/0000-0002-6068-5289
Osamu ShionoDepartment of Otorhinolaryngology, Yokohama Rosai Hospital, Yokohama, Japan.ORCID http://orcid.org/0000-0001-9540-2034
Masataka TaguriDepartment of Data Science, School of Data Science, Yokohama City University, Yokohama, Japan.ORCID http://orcid.org/0000-0001-8902-0056
Masanori KomatsuDepartment of Otorhinolaryngology, Yokohama City University Medical Center, Yokohama, Japan.ORCID http://orcid.org/0000-0001-5541-0179
Daisuke SanoDepartment of Otorhinolaryngology, Head and Neck Surgery, School of Medicine, Yokohama City University, Yokohama, Japan.ORCID http://orcid.org/0000-0002-7686-4724
Naoko SakumaDepartment of Otorhinolaryngology, Yokohama City University Medical Center, Yokohama, Japan.ORCID http://orcid.org/0000-0001-7725-4066
Kenichiro YabukiDepartment of Otorhinolaryngology, Head and Neck Surgery, School of Medicine, Yokohama City University, Yokohama, Japan.ORCID http://orcid.org/0000-0002-5099-1901
Yasuhiro AraiDepartment of Otorhinolaryngology, Head and Neck Surgery, School of Medicine, Yokohama City University, Yokohama, Japan.ORCID http://orcid.org/0000-0002-3622-4482
Kunihiko ShibataDepartment of Otorhinolaryngology, Yokohama City University Medical Center, Yokohama, Japan.ORCID http://orcid.org/0000-0001-9665-7135
Yoshihiro ChibaDepartment of Otorhinolaryngology, Head and Neck Surgery, School of Medicine, Yokohama City University, Yokohama, Japan.ORCID http://orcid.org/0000-0001-7364-4681
Teruhiko TanabeDepartment of Otorhinolaryngology, Head and Neck Surgery, School of Medicine, Yokohama City University, Yokohama, Japan.ORCID http://orcid.org/0000-0002-1870-516X
Nobuhiko OridateDepartment of Otorhinolaryngology, Head and Neck Surgery, School of Medicine, Yokohama City University, Yokohama, Japan.ORCID http://orcid.org/0000-0002-6968-3028
Yokohama City University · JPYokohama City University Medical Center · JPYokohama Rosai Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWe confirmed the safety of postoperative bio-chemoradiotherapy using cetuximab and docetaxel in a small number of patients with cis-platinum-intolerant core high-risk head and neck cancer.

objectiveTo assess treatment efficacy, we planned a phase 2 study of postoperative bio-chemoradiotherapy for patients with cis-platinum-intolerant core high-risk head and neck cancer and will compare the results to those of previously collected radiotherapy data.

methodsPatients who underwent definitive surgery for oral cavity, laryngeal, oropharyngeal, or hypopharyngeal advanced cancer, whose postoperative pathological results indicated core high risk for recurrence (eg, positive margin in the primary site or extranodal extension) and who were cis-platinum-intolerant, will undergo postoperative bio-chemoradiotherapy. The primary end point is 2-year disease-free survival.

resultsThe expected 2-year disease-free survival is set at 55%, and the calculated sample size is 35 patients, according to a statistical analysis based on previous reports.

conclusionsThis treatment method is expected to improve the survival rate of patients with severe head and neck cancer.

trial registrationUMIN Clinical Trials Registry UMIN000031835; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ ctr_view.cgi?recptno=R000036355 (Archived by WebCite at http://www.webcitation.org/71fejVjMr).

Indexed as

cetuximabcis-platinum intolerantcore high-risk head and neck cancerdocetaxelpostoperative bio-chemoradiotherapy

Identifiers

PMID30139721
PMCPMC6127497
OpenAlexW2809518253

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.