Evidence map›Paper›PMID 36603849›Full record

Trial reportJournal of gynecologic oncology2023

Phase I/II prospective clinical trial for the hybrid of intracavitary and interstitial brachytherapy for locally advanced uterine cervical cancer.

Naoya Murakami, Miho Watanabe, Takashi Uno, Shuhei Sekii, Kayoko Tsujino, Takahiro Kasamatsu, Yumiko Machitori, Tomomi Aoshika, Shingo Kato, Hisako Hirowatari and 24 more

Open access · diamondAbstract readClinical Trial, Phase IIClinical Trial, Phase I
In one paragraph

Trial report in Journal of gynecologic oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
3.0field-weighted citation impact, top 9% 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

9 citing papers in PubMed, 10 citations in OpenAlex.

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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

34 authors at 20 institutions in 1 country.

Naoya MurakamiDepartment of Radiation Oncology, National Cancer Center Hospital, Tokyo, Japan. namuraka@ncc.go.jp.ORCID 0000-0003-0660-9987
Miho WatanabeDiagnostic Radiology and Radiation Oncology, Graduate School of Medicine, Chiba University, Chiba, Japan.ORCID 0000-0003-0962-4429
Takashi UnoDiagnostic Radiology and Radiation Oncology, Graduate School of Medicine, Chiba University, Chiba, Japan.ORCID 0000-0003-4606-5662
Shuhei SekiiDepartment of Radiation Oncology, Hyogo Cancer Center, Hyogo, Japan.ORCID 0000-0002-1958-9295
Kayoko TsujinoDepartment of Radiation Oncology, Hyogo Cancer Center, Hyogo, Japan.ORCID 0000-0002-8679-298X
Takahiro KasamatsuDepartment of Obstetrics and Gynecology, Tokyo Metropolitan Bokutoh Hospital, Tokyo, Japan.ORCID 0000-0003-0693-3250
Yumiko MachitoriDepartment of Radiology, Tokyo Metropolitan Bokutoh Hospital, Tokyo, Japan.ORCID 0000-0001-7808-9795
Tomomi AoshikaDepartment of Radiation Oncology, Saitama Medical University International Medical Center, Saitama, Japan.ORCID 0000-0002-3803-9336
Shingo KatoDepartment of Radiation Oncology, Saitama Medical University International Medical Center, Saitama, Japan.ORCID 0000-0002-6699-9334
Hisako HirowatariDepartment of Radiology, Tokyo Rinkai Hospital, Tokyo, Japan.ORCID 0000-0002-9372-6825
Yuko KaneyasuDepartment of Radiation Oncology, National Hospital Organization Fukuyama Medical Center, Hiroshima, Japan.ORCID 0000-0002-3105-0719
Tomio NakagawaDepartment of Radiation Oncology, National Hospital Organization Fukuyama Medical Center, Hiroshima, Japan.ORCID 0000-0003-3684-6393
Hitoshi IkushimaDepartment of Therapeutic Radiology, Tokushima University Graduate School, Tokushima, Japan.ORCID 0000-0003-1578-4293
Ken AndoDepartment of Radiation Oncology, Gunma Prefectural Cancer Center, Gunma, Japan.ORCID 0000-0003-4011-622X
Masumi MurataDepartment of Radiation Oncology, Gunma Prefectural Cancer Center, Gunma, Japan.ORCID 0000-0001-7002-5789
Ken YoshidaDepartment of Radiation Oncology, Osaka Medical and Pharmaceutical University, Osaka, Japan.ORCID 0000-0002-8083-7825
Hiroto YoshiokaDepartment of Radiation Oncology, Osaka Medical and Pharmaceutical University, Osaka, Japan.ORCID 0000-0003-2922-7420
Kazutoshi MurataDepartment of Radiation Oncology, Gunma University Graduate School of Medicine, Gunma, Japan.ORCID 0000-0003-1836-6353
Tatsuya OhnoDepartment of Radiation Oncology, Gunma University Graduate School of Medicine, Gunma, Japan.ORCID 0000-0002-6703-3144
Noriyuki OkonogiQST Hospital, National Institutes for Quantum Science and Technology, Chiba, Japan.ORCID 0000-0002-9486-1922
Anneyuko I SaitoDepartment of Radiation Oncology, Juntendo University Faculty of Medicine, Tokyo, Japan.ORCID 0000-0001-9534-6597
Mayumi IchikawaDepartment of Radiation Oncology, Yamagata University Faculty of Medicine, Yamagata, Japan.ORCID 0000-0001-8092-3371
Takahito OkudaDepartment of Radiation Oncology, Toyota Memorial Hospital, Aichi, Japan.ORCID 0000-0002-2543-9584
Keisuke TsuchidaDepartment of Radiation Oncology, Kanagawa Cancer Center, Kanagawa, Japan.ORCID 0000-0002-3548-6472
Hideyuki SakuraiDepartment of Radiation Oncology, University of Tsukuba Faculty of Medicine, Ibaraki, Japan.ORCID 0000-0002-0576-8639
Ryoichi YoshimuraDepartment of Radiation Therapeutics and Oncology, Tokyo Medical Dental University, Tokyo, Japan.ORCID 0000-0001-9435-1503
Yasuo YoshiokaRadiation Oncology Department, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.ORCID 0000-0003-1225-2910
Atsunori YorozuDepartment of Radiation Oncology, National Hospital Organization Tokyo Medical Center, Tokyo, Japan.ORCID 0000-0002-4808-7147
Naonobu KunitakeDepartment of Radiation Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.ORCID 0000-0002-2735-9705
Hiroyuki OkamotoRadiation Safety and Quality Assurance Division, National Cancer Center Hospital, Tokyo, Japan.ORCID 0000-0001-9491-787X
Koji InabaDepartment of Radiation Oncology, National Cancer Center Hospital, Tokyo, Japan.ORCID 0000-0002-6712-2294
Tomoyasu KatoDepartment of Gynecologic Oncology, National Cancer Center Hospital, Tokyo, Japan.ORCID 0000-0001-9561-1522
Hiroshi IgakiDepartment of Radiation Oncology, National Cancer Center Hospital, Tokyo, Japan. hirigaki@ncc.go.jp.ORCID 0000-0001-7817-624X
Jun ItamiDepartment of Radiation Oncology, National Cancer Center Hospital, Tokyo, Japan.ORCID 0000-0003-1579-7406
Tokyo National Hospital · JPGunma University · JPChiba University · JPFukuyama Cardiovascular Hospital · JPSaitama Medical University · JPTokyo Metropolitan Bokutoh Hospital · JPHyogo Prefectural Cancer Center · JPJapanese Foundation For Cancer Research · JPJuntendo University · JPKanagawa Prefectural Hospital Organization · JPKansai Medical University · JPNational Cancer Center Hospital East · JPNational Hospital Organization Kyushu Cancer Center · 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 · JP

Funding

Japan Agency for Medical Research and Development 19ck0106305h0003National Cancer Center Research and Development Fund 26-A-18National Cancer Center Research and Development Fund 26-A-28
6 · The paper itself

Abstract

objectiveThe purposes of this trial were to demonstrate the feasibility and effectiveness of the hybrid of intracavitary and interstitial brachytherapy (HBT) for locally advanced cervical cancer patients in the phase I/II prospective clinical trial.

methodsPatients with FIGO stage IB2-IVA uterine cervical cancer pretreatment width of which was ≥5 cm measured by magnetic resonance imaging were eligible for this clinical trial. The protocol therapy included 30-30.6 Gy in 15-17 fractions of whole pelvic radiotherapy concurrent with weekly CDDP, followed by 24 Gy in 4 fractions of HBT and pelvic radiotherapy with a central shield up to 50-50.4 Gy in 25-28 fractions. The primary endpoint of phase II part was 2-year pelvic progression-free survival (PPFS) rate higher than historical control of 64%.

resultsBetween October 2015 and October 2019, 73 patients were enrolled in the initial registration and 52 patients proceeded to the secondary registration. With the median follow-up period of 37.3 months (range, 13.9-52.9 months), the 2- PPFS was 80.7% (90% confidence interval [CI]=69.7%-88%). Because the lower range of 90% CI of 2-year PPFS was 69.7%, which was higher than the historical control ICBT data of 64%, therefore, the primary endpoint of this study was met.

conclusionThe effectiveness of HBT were demonstrated by a prospective clinical study. Because the dose goal determined in the protocol was lower than 85 Gy, there is room in improvement for local control. A higher dose might have been needed for tumors with poor responses.

Indexed as

BrachytherapyUterine Cervical NeoplasmsFemaleHumansPelvisProspective StudiesRadiotherapy DosageCervical CancerIC/ISImage Guided Adaptive BrachytherapyIntracavitary and Interstitial Brachytherapy

Identifiers

PMID36603849
PMCPMC10157336
OpenAlexW4313586327

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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.