Evidence map›Paper›PMID 28429140›Full record

Trial reportInternational journal of clinical oncology2017

A phase I/II study on stereotactic body radiotherapy with real-time tumor tracking using CyberKnife based on the Monte Carlo algorithm for lung tumors.

Hiromitsu Iwata, Satoshi Ishikura, Taro Murai, Michio Iwabuchi, Mitsuhiro Inoue, Koshi Tatewaki, Seiji Ohta, Naoki Yokota, Yuta Shibamoto

Abstract readClinical Trial, Phase IClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in International journal of clinical oncology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing 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

10 citing papers in PubMed.

  1. Observational
  2. Review
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Breathing-motion-compensated robotic guided stereotactic body radiation therapy : Patterns of failure analysis.Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2018
    Article
  9. Article
  10. 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

9 authors.

Hiromitsu IwataDepartment of Radiation Oncology, Nagoya Proton Therapy Center, Nagoya City West Medical Center, 1-1-1 Hirate-cho, Kita-ku, Nagoya, 462-8508, Japan. h-iwa-ncu@nifty.com.
Satoshi IshikuraDepartment of Radiology, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan.
Taro MuraiDepartment of Radiology, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan.
Michio IwabuchiDepartment of Radiology, Yokohama CyberKnife Center, 574-1 Ichizawa-cho, Asahi-ku, Yokohama, 241-0014, Japan.
Mitsuhiro InoueDivision of Quality Management with Radiation, Yokohama CyberKnife Center, 574-1 Ichizawa-cho, Asahi-ku, Yokohama, 241-0014, Japan.
Koshi TatewakiDepartment of Neurosurgery, Yokohama CyberKnife Center, 574-1 Ichizawa-cho, Asahi-ku, Yokohama, 241-0014, Japan.
Seiji OhtaDepartment of Neurosurgery, Yokohama CyberKnife Center, 574-1 Ichizawa-cho, Asahi-ku, Yokohama, 241-0014, Japan.
Naoki YokotaRadiation Oncology Center, Suzukake Central Hospital, 120-1 Tajiri-cho, Minami-Ku, Hamamatsu, 432-8054, Japan.
Yuta ShibamotoDepartment of Radiology, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn this phase I/II study, we assessed the safety and initial efficacy of stereotactic body radiotherapy (SBRT) for lung tumors with real-time tumor tracking using CyberKnife based on the Monte Carlo algorithm.

methodsStudy subjects had histologically confirmed primary non-small-cell lung cancer staged as T1a-T2aN0M0 and pulmonary oligometastasis. The primary endpoint was the incidence of Grade ≥3 radiation pneumonitis (RP) within 180 days of the start of SBRT. The secondary endpoint was local control and overall survival rates. Five patients were initially enrolled at level 1 [50 Gy/4 fractions (Fr)]; during the observation period, level 0 (45 Gy/4 Fr) was opened. The dose was escalated to the next level when grade ≥3 RP was observed in 0 out of 5 or 1 out of 10 patients. Virtual quality assurance planning was performed for 60 Gy/4 Fr; however, dose constraints for the organs at risk did not appear to be within acceptable ranges. Therefore, level 2 (55 Gy/4 Fr) was regarded as the upper limit. After the recommended dose (RD) was established, 15 additional patients were enrolled at the RD. The prescribed dose was normalized at the 95% volume border of the planning target volume based on the Monte Carlo algorithm.

resultsBetween September 2011 and September 2015, 40 patients (primary 30; metastasis 10) were enrolled. Five patients were enrolled at level 0, 15 at level 1, and 20 at level 2. Only one grade 3 RP was observed at level 1. Two-year local control and overall survival rates were 98 and 81%, respectively.

conclusionThe RD was 55 Gy/4 Fr. SBRT with real-time tumor tracking using CyberKnife based on the Monte Carlo algorithm was tolerated well and appeared to be effective for solitary lung tumors.

Indexed as

AgedAged, 80 and overAlgorithmsCarcinoma, Non-Small-Cell LungFemaleHumansLung NeoplasmsMaleMiddle AgedMonte Carlo MethodRadiosurgeryRadiotherapy DosageRadiotherapy Planning, Computer-AssistedTreatment OutcomeCyberKnifeLung tumorsMonte Carlo algorithmPhase I/II studyStereotactic body radiotherapyTracking

Identifiers

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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.