Evidence map›Paper›PMID 35470390›Full record

Trial reportJapanese journal of clinical oncology2022

Large volume was associated with increased risk of acute non-hematologic adverse events in the hybrid of intracavitary and interstitial brachytherapy for locally advanced uterine cervical cancer: preliminary results of prospective phase I/II clinical trial.

Naoya Murakami, Miho Watanabe, Takashi Uno, Shuhei Sekii, Kayoko Tsujino, Takahiro Kasamatsu, Yumiko Machitori, Tomomi Aoshika, Shingo Kato, Hisako Hirowatari and 23 more

Erratum issuedOpen access · bronzeAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Japanese journal of clinical oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.5field-weighted citation impact, top 19% 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, 8 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
  4. Long-Term Efficacy and Toxicity of Intensity-Modulated Radiotherapy in Bulky Cervical Cancer.International journal of environmental research and public health · 2023
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

33 authors at 20 institutions in 1 country.

Naoya MurakamiDepartment of Radiation Oncology, National Cancer Center Hospital, Tokyo, Japan.ORCID 0000-0003-0660-9987
Miho WatanabeDiagnostic Radiology and Radiation Oncology, Graduate School of Medicine, Chiba University, Chiba, Japan.
Takashi UnoDiagnostic Radiology and Radiation Oncology, Graduate School of Medicine, Chiba University, Chiba, Japan.
Shuhei SekiiDepartment of Radiation Therapy, Kitaharima Medical Center, Ono, Japan.
Kayoko TsujinoDepartment of Radiation Oncology, Hyogo Cancer Center, Akashi, Japan.
Takahiro KasamatsuDepartment of Obstetrics and Gynecology, Tokyo Metropolitan Bokutoh Hospital, Tokyo, Japan.
Yumiko MachitoriDepartment of Radiology, Tokyo Metropolitan Bokutoh Hospital, Tokyo, Japan.
Tomomi AoshikaDepartment of Radiation Oncology, Saitama Medical University International Medical Center, Hidaka, Japan.ORCID 0000-0002-3803-9336
Shingo KatoDepartment of Radiation Oncology, Saitama Medical University International Medical Center, Hidaka, Japan.
Hisako HirowatariDepartment of Radiology, Tokyo Rinkai Hospital, Tokyo, Japan.
Yuko KaneyasuDepartment of Radiation Oncology, National Hospital Organisation Fukuyama Medical Center, Fukuyama, Japan.
Tomio NakagawaDepartment of Radiation Oncology, National Hospital Organisation Fukuyama Medical Center, Fukuyama, Japan.
Hitoshi IkushimaDepartment of Therapeutic Radiology, Tokushima University Graduate School of Medicine, Tokushima, Japan.
Ken AndoDepartment of Radiation Oncology, Gunma Prefectural Cancer Center, Ota, Japan.
Masumi MurataDepartment of Radiation Oncology, Gunma Prefectural Cancer Center, Ota, Japan.
Ken YoshidaDepartment of Radiation Oncology, Osaka Medical and Pharmaceutical University, Osaka, Japan.
Hiroto YoshiokaDepartment of Radiation Oncology, Osaka Medical and Pharmaceutical University, Osaka, Japan.
Kazutoshi MurataDepartment of Radiation Oncology, Gunma University Graduate School of Medicine, Maebashi, Japan.
Tatsuya OhnoDepartment of Radiation Oncology, Gunma University Graduate School of Medicine, Maebashi, Japan.
Noriyuki OkonogiDepartment of Radiation Oncology, QST Hospital, National Institutes for Quantum Science and Technology, Chiba, Japan.
Anneyuko SaitoDepartment of Radiation Oncology, Juntendo University School of Medicine Graduate School of Medicine, Tokyo, Japan.
Mayumi IchikawaDepartment of Radiation Oncology, Yamagata University Faculty of Medicine Graduate School of Medical Science, Yamagata, Japan.
Takahito OkudaDepartment of Radiation Oncology, Toyota Memorial Hospital, Toyota, Japan.
Keisuke TsuchidaDepartment of Radiation Oncology, Kanagawa Cancer Center, Yokohama, Japan.
Hideyuki SakuraiDepartment of Radiation Oncology, University of Tsukuba Faculty of Medicine, Tsukuba, Japan.
Ryouichi YoshimuraDepartment of Radiation Therapeutics and Oncology, Tokyo Medical and Dental University, Tokyo, Japan.
Yasuo YoshiokaDepartment of Radiation Oncology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.
Atsunori YorozuDepartment of Radiation Oncology, National Hospital Organisation Tokyo Medical Center, Tokyo, Japan.
Horoyuki OkamotoRadiation Safety and Quality Assurance Division, National Cancer Center Hospital, Tokyo, Japan.
Koji InabaDepartment of Radiation Oncology, National Cancer Center Hospital, Tokyo, Japan.
Tomoyasu KatoDepartment of Gynecologic Oncology, National Cancer Center Hospital, Tokyo, Japan.
Hiroshi IgakiDepartment of Radiation Oncology, National Cancer Center Hospital, Tokyo, Japan.ORCID 0000-0001-7817-624X
Jun ItamiDepartment of Radiation Oncology, National Cancer Center Hospital, Tokyo, Japan.
Tokyo National Hospital · JPGunma University · JPChiba University · JPFukuyama Cardiovascular Hospital · JPHyogo Prefectural Cancer Center · JPSaitama Medical University · JPTokyo Metropolitan Bokutoh Hospital · JPJapanese Foundation For Cancer Research · JPJuntendo University · JPKanagawa Prefectural Hospital Organization · JPKansai Medical University · JPNational Cancer Center Hospital East · JPNational Institutes for Quantum Science and Technology · JPOsaka University of Pharmaceutical Sciences · JPTokushima University · JPTokyo-Kita Medical Center · JPTokyo Medical and Dental University · JPTokyo Medical Center · JPTokyo Rinkai Hospital · JPToyota Memorial Hospital · JP

Funding

Japan Agency for Medical Research and Development 19ck0106305h0003National Cancer Center Research and Development Fund 26-A-18
6 · The paper itself

Abstract

objectiveThis is the preliminary results of a multi-center prospective clinical trial evaluating the feasibility of the hybrid of intracavitary and interstitial brachytherapy for locally advanced cervical cancer.

methodsPatients with FIGO stage IB2, IIA2, IIB, IIIA, IIIB and IVA uterine cervical cancer pretreatment width of which was ≥5 cm measured by MRI were eligible. Protocol therapy consisted of 30-30.6 Gy in 15-17 fractions of whole pelvic radiotherapy concurrent with weekly CDDP, followed by 24 Gy in 4 fractions of hybrid of intracavitary and interstitial and pelvic radiotherapy with central shield up to 50-50.4 Gy in 25-28 fractions. The primary endpoint of phase I part was that the rate of grade ≥ 3 acute non-hematologic adverse events related to hybrid of intracavitary and interstitial would be <10%.

resultsBetween October 2015 and October 2019, 74 patients underwent primary registration, with 52 patients eventually proceeding to the secondary registration. The median pretreatment tumor width was 5.7 cm, and FIGO Stages were IB2 10, IIA2 2, IIB 20 and IIIB 20, respectively. The median high-risk clinical target volume D90 was 72.0 Gy (54.8-86.6 Gy, EQD2), rectum D2cc was 53.7 Gy (29.3-80.3 Gy) and bladder D2cc was 69.8 Gy (38.9-84.8 Gy). The rate of grade ≥ 3 non-hematologic adverse events related to hybrid of intracavitary and interstitial was 1.9% (1/52), and 17.3% (9/52) of patients experienced non-hematologic adverse events related to hybrid of intracavitary and interstitial of any grade. In multivariate analysis, high-risk clinical target volume ≥ 35 ml was associated with an increased risk of any grade of acute non-hematologic adverse events related to hybrid of intracavitary and interstitial (P = 0.036).

conclusionThe feasibility and reproducibility of hybrid of intracavitary and interstitial were demonstrated from a multi-center prospective clinical trial.

Indexed as

BrachytherapyUterine Cervical NeoplasmsFemaleHumansProspective StudiesRadiotherapy DosageReproducibility of Resultscombined intracavitary/interstitial brachytherapyhybrid of intracavitary and interstitial brachytherapyimage-guided adaptive brachytherapyprospective clinical trialuterine cervical cancer

Identifiers

PMID35470390
OpenAlexW4224944022

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.