Evidence map›Paper›PMID 37932681›Full record

Trial reportBMC cancer2023

Novel approach of prophylactic radiation to reduce toxicities comparing 2-step40 with 56-Gy simultaneous integrated boost intensity-modulated radiation therapy for locally advanced squamous cell carcinoma of the head and neck, an intergroup phase III trial (JCOG1912, NEW BRIDGE).

Tomoya Yokota, Sadamoto Zenda, Takeshi Kodaira, Naomi Kiyota, Yasushi Fujimoto, Koichiro Wasano, Ryo Takahashi, Takashi Mizowaki, Akihiro Homma, Keita Sasaki and 5 more

Open access · greenAbstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase III
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC cancer, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact, top 100% 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

4 citing papers in PubMed, 0 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. 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

15 authors at 9 institutions in 1 country.

Tomoya YokotaDivision of Gastrointestinal Oncology, Shizuoka Cancer Center, Sunto-gun, Japan.
Sadamoto ZendaDepartment of Radiation Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
Takeshi KodairaDepartment of Radiation Oncology, Aichi Cancer Center Hospital, Nagoya, Japan, 1-1 Kanoko-den, Chikusa-ku, Nagoya, Aichi, 464-8681, Japan. 109103@aichi-cc.jp.
Naomi KiyotaDepartment of Medical Oncology and Hematology, Cancer Center, Kobe University Hospital, Kobe, Japan.
Yasushi FujimotoDepartment of Otolaryngology, Aichi Medical University, Nagakute, Japan.
Koichiro WasanoDepartment of Otolaryngology-Head and Neck Surgery, Tokai University School of Medicine, Isehara, Japan.
Ryo TakahashiSection of Radiation Safety and Quality Assurance, National Cancer Center Hospital East, Kashiwa, Japan.
Takashi MizowakiDepartments of Radiation Oncology and Image-Applied Therapy, Kyoto University Graduate School of Medicine, Kyoto, Japan.
Akihiro HommaDepartment of Otolaryngology-Head and Neck Surgery, Faculty of Medicine, Graduate School of Medicine, Hokkaido University, Sapporo, Japan.
Keita SasakiJapan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.
Ryunosuke MachidaJapan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.
Yuta SekinoJapan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.
Haruhiko FukudaJapan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.
Japan Clinical Oncology Group Radiation Therapy Study Group
Japan Clinical Oncology Group Head and Neck Cancer Study Group
Japan Clinical Cancer Research Organization · JPNational Cancer Center Hospital East · JPAichi Cancer Center · JPAichi Medical University · JPHokkaido University · JPKobe University Hospital · JPKyoto University · JPShizuoka Cancer Center · JPTokai University · JP

Funding

Japan Agency for Medical Research and Development 22ck0106751h0001National Cancer Center Research and Development Funds 2023-J-3
6 · The paper itself

Abstract

backgroundChemoradiotherapy (CRT) with concurrent cisplatin is the standard of care as a nonsurgical definitive treatment for patients with locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN). However, CRT is associated with increased severe late adverse events, including swallowing dysfunction, xerostomia, ototoxicity, and hypothyroidism. Few strategies aimed at less invasive CRT without compromising treatment outcomes have been successful. The purpose of this study is to confirm the non-inferiority of reduced dose prophylactic radiation with 40 Gy compared to standard dose prophylactic radiation with 56 Gy in terms of the time to treatment failure (TTF) among patients with clinical stage III-IVB LA-SCCHN.

methodsThis study is a multicenter, two-arm, open-label, randomized phase III trial. Patients with LA-SCCHN excluding p16 positive oropharynx cancer are randomized to the standard arm or experimental arm. A total dose of 70 Gy for tumors with concurrent cisplatin at 100 mg/m DISCUSSION: If the experimental arm is non-inferior to the standard arm in terms of TTF and superior on the safety endpoints, the 2-step40 procedure is the more useful treatment than SIB56 for definitive CRT.

trial registrationThis trial has been registered in the Japan Registry of Clinical Trials as jRCTs031210100 ( https://jrct.niph.go.jp/latest-detail/jRCTs031210100 ). Date of Registration: May 2021.

Indexed as

Carcinoma, Squamous CellHead and Neck NeoplasmsChemoradiotherapyCisplatinHumansNeoplasm Recurrence, LocalQuality of LifeSquamous Cell Carcinoma of Head and NeckCisplatin2-stepChemoradiotherapyIntensity modulated radiation therapyLocally advanced head and neck cancerProphylactic radiationRandomized controlled studySimultaneous integrated boost

Identifiers

PMID37932681
PMCPMC10626703
OpenAlexW37932681

What OpenQuestion holds

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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.