Evidence map›Paper›PMID 30325662›Full record

ArticleThe British journal of radiology2019

Dose escalation in extracranial stereotactic ablative radiotherapy (DESTROY-1): A multiarm Phase I trial.

Francesco Deodato, Gabriella Macchia, Savino Cilla, Anna Ianiro, Giuseppina Sallustio, Silvia Cammelli, Milly Buwenge, Gian Carlo Mattiucci, Vincenzo Valentini, Alessio G Morganti

Open access · greenAbstract readClinical Trial, Phase I
In one paragraph

Article in The British journal of radiology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.9field-weighted citation impact, top 15% 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

5 citing papers in PubMed, 16 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

10 authors at 2 institutions in 2 countries.

Francesco Deodato1 Radiotherapy Unit, "Giovanni Paolo II" Foundation, Catholic University of Sacred Heart , Campobasso , Italy.
Gabriella Macchia1 Radiotherapy Unit, "Giovanni Paolo II" Foundation, Catholic University of Sacred Heart , Campobasso , Italy.ORCID http://orcid.org/0000-0002-0529-201X
Savino Cilla2 Medical Physics Unit, "Giovanni Paolo II" Foundation, Catholic University of Sacred Heart , Campobasso , Italy.
Anna Ianiro2 Medical Physics Unit, "Giovanni Paolo II" Foundation, Catholic University of Sacred Heart , Campobasso , Italy.
Giuseppina Sallustio3 Radiology Unit, "Giovanni Paolo II" Foundation, Catholic University of Sacred Heart , Campobasso , Italy.
Silvia Cammelli4 Department of Experimental, Diagnostic and Specialty Medicine -DIMES, Radiation Oncology Unit, University of Bologna, S. Orsola-Malpighi Hospital , Bologna , Italy.
Milly Buwenge4 Department of Experimental, Diagnostic and Specialty Medicine -DIMES, Radiation Oncology Unit, University of Bologna, S. Orsola-Malpighi Hospital , Bologna , Italy.
Gian Carlo Mattiucci5 Dipartimento di Diagnostica per immagini, Radioterapia Oncologica ed Ematologia, Gemelli ART (Advanced Radiation Therapy) - Interventional Oncology Center, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Università Cattolica del Sacro Cuore , Rome , Italy.
Vincenzo Valentini5 Dipartimento di Diagnostica per immagini, Radioterapia Oncologica ed Ematologia, Gemelli ART (Advanced Radiation Therapy) - Interventional Oncology Center, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Università Cattolica del Sacro Cuore , Rome , Italy.
Alessio G Morganti4 Department of Experimental, Diagnostic and Specialty Medicine -DIMES, Radiation Oncology Unit, University of Bologna, S. Orsola-Malpighi Hospital , Bologna , Italy.
Università Cattolica del Sacro Cuore · ITIRCCS Azienda Ospedliero-Universitaria di Bologna Policlinico di Sant'Orsola · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objective: A multiarm Phase I clinical trial was performed to define the maximum tolerated dose (MTD) of stereotactic body radiotherapy (SBRT) delivered by non-coplanar conformal beams or volumetric modulated arc therapy technique in seven predefined clinical settings.

methods: The (a) and (b) arms investigated primary and metastatic lung cancer differentiated by site of onset, arm (c) included primary or metastatic lesions outside the thorax, the (d) and (e) arms were for in-field reirradiation of recurrence, and finally, the (f) and (g) arms were for boost irradiation to the lesions after an adjuvant RT prescribed dose. A 4 months cut-off after previous irradiation course was fixed to distinguish the boost from the retreatment (<4 vs >4 months, respectively). Patients were prospectively enrolled in study arms according to tumor site, clinical stage and previous treatment. The total dose prescribed to the isocenter, ranged from 20 to 50 Gy according to the protocol design and the doses per fraction ranged from 4 to 10 Gy in 5 days.

results: A total of 281 patients (M/F: 167/114; median age: 69 years) with 376 lesions underwent SBRT. No acute toxicity was reported in 175 patients (62.3%) while 106 (37.7%) experienced only low-grade (G < 2) acute toxicity. Four patients (all previously irradiated in the same site) showed >Grade 2 toxicity within 6 months from SBRT. With a median follow-up of 19 months, 204 patients (72.6%) did not experience late toxicity, and 77 (27.4%) experienced low grade late toxicity. On per-lesion basis, the 12-and 24 months actuarial local control inside the SBRT field were 84.3 and 73.7 %, respectively.

conclusions: SBRT delivered in five consecutive fractions up to the doses evaluated is well tolerated. The MTD was reached in four (a, b, c and f) of the seven study arms. Recruitment for (d), (e) and (g) arms is still ongoing. ADVANCES IN KNOWLEDGE:: In a prospective dose-escalation trial, the MTD of 50 Gy/10 Gy fraction and 35 Gy/7 Gy fraction were defined for primary and metastatic lesions and as boost after prior RT dose ≤50 Gy, respectively.

Indexed as

RadiosurgeryRadiotherapy DosageAdultAgedAged, 80 and overDose Fractionation, RadiationDose-Response Relationship, RadiationFemaleHumansMaleMaximum Tolerated DoseMiddle AgedNeoplasm MetastasisNeoplasmsProspective StudiesRadiotherapy Planning, Computer-Assisted

Identifiers

PMID30325662
PMCPMC6404833
OpenAlexW2895886788

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.