Evidence map›Paper›PMID 27531238›Full record

Trial reportBMC cancer2016

A phase I/II clinical trial for the hybrid of intracavitary and interstitial brachytherapy for locally advanced cervical cancer.

Naoya Murakami, Shingo Kato, Takashi Nakano, Takashi Uno, Takeharu Yamanaka, Hideyuki Sakurai, Ryoichi Yoshimura, Junichi Hiratsuka, Yuki Kuroda, Kotaro Yoshio and 1 more

Abstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC cancer, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–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

6 citing papers in PubMed.

  1. Trial
  2. Brachytherapy use in cervical cancer: a narrative review.Gynecology and pelvic medicine · 2026
    Review
  3. Article
  4. Article
  5. Review
  6. 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

11 authors.

Naoya MurakamiDepartment of Radiation Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan. namuraka@ncc.go.jp.
Shingo KatoDepartment of Radiation Oncology, International Medical Center, Saitama Medical University, 1397-1 Yamane, Hidaka-shi, Saitama, Japan.
Takashi NakanoDepartment of Radiation Oncology, Gunma University Graduate School of Medicine, 3-39-45 Showamachi, Maebashi, Gunma, Japan.
Takashi UnoDiagnostic Radiology and Radiation Oncology, Graduate School of Medicine, Chiba University, 1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, 260-8670, Japan.
Takeharu YamanakaDepartment of Biostatistics, Yokohama City University, 22-2 Seto, Kanazawa-ku, Yokohama, 236-0027, Japan.
Hideyuki SakuraiDepartment of Radiation Oncology, University of Tsukuba, 1-1-1 Tennodai, Tsukuba, Ibaraki, 305-8575, Japan.
Ryoichi YoshimuraDepartment of Radiation Therapeutics and Oncology, Tokyo Medical and Dental University, 5-45, Yushima 1-chome, Bunkyo-ku, Tokyo, 113-8519, Japan.
Junichi HiratsukaDepartment of Radiation Oncology, Kawasaki Medical School, Matsushima 577, Kurashiki, Japan.
Yuki KurodaDepartment of Radiation Oncology, Yamagata University Faculty of Medicine, Yamagata, 990-9585, Japan.
Kotaro YoshioDepartment of Radiology, Kagawa Prefectural Central Hospital, 1-2-1 Asahi-cho, Takamatsu-shi, Kagawa, Japan.
Jun ItamiDepartment of Radiation Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis paper describes about a study protocol of phase I/II multicenter prospective clinical trial evaluating the feasibility and efficacy of the hybrid of intracavitary and interstitial brachytherapy (HBT) for locally advanced uterine cervical cancer patients. METHODS AND

designPatients with histologically confirmed FIGO stage IB2, IIA2, IIB, and IIIB uterine cervical carcinoma width of which is larger than 5 cm assessed by MRI will be entered to this clinical trial. Protocol therapy is 30-30.6 Gy in 15-17 fractions of whole pelvic radiotherapy concurrent with weekly CDDP (40 mg/m(2)), followed by 24 Gy in 4 fractions of HBT and central shield EBRT up to 50-50.4 Gy in 25-28 fractions. Tumor width is assessed again within one week before the first HBT and if the tumor width is larger than 4 cm, patients proceed to the secondary registration. In phase I section, feasibility of this will be investigated. If less than 10 % out of 20 patients experienced greater than grade 3 acute non-hematologic adverse effects, the study proceeds to phase II part. In phase II part a total of 55 patients will be accrued and the efficacy of the HBT will be investigated comparing with historical control data. If the lower margin of 90 % confidence interval of the 2-year pelvic progression-free survival of the HBT trial is higher than 64 %, the HBT is considered to be more effective than conventional ICBT. DISCUSSION: The aim of this study is to demonstrate the feasibility and efficacy of the HBT for locally advanced cervical cancer. This trial will clarify the indication, feasibility, and efficacy of this new technique.

trial registrationUMIN000019081 ; Registration date: 2015/9/30.

Indexed as

AdultAgedAntineoplastic AgentsBrachytherapyCisplatinDose Fractionation, RadiationFeasibility StudiesFemaleHumansMiddle AgedProspective StudiesRadiotherapyRadiotherapy DosageSurvival AnalysisTreatment OutcomeUterine Cervical NeoplasmsAntineoplastic AgentsCisplatinA prospective clinical trial protocolHybrid of intracavitary and interstitial brachytherapyUterine cervical cancer

Identifiers

PMID27531238
PMCPMC4987974

What OpenQuestion holds

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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.