Evidence map›Paper›PMID 33001241›Full record

Trial reportStrahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al]2021

Adjuvant hypofractionated radiotherapy with simultaneous integrated boost after breast-conserving surgery: results of a prospective trial.

David Krug, René Baumann, Katja Krockenberger, Reinhard Vonthein, Andreas Schreiber, Alexander Boicev, Florian Würschmidt, Evelyn Weinstrauch, Kirsten Eilf, Peter Andreas and 6 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al], 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01948726 (Multicenter Phase-II-Trial of Evaluation of Acute Toxicity in Hypofractionation With Simultaneous Integrated Boost for Early Breast Cancer), which is not on this map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
1.7field-weighted citation impact, top 16% 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.

NCT01948726 nacompletednot on this map

Multicenter Phase-II-Trial of Evaluation of Acute Toxicity in Hypofractionation With Simultaneous Integrated Boost for Early Breast Cancer

TypeinterventionalSponsorUniversity Hospital Schleswig-HolsteinRan2013 to 2015Enrolled150ConditionsBreast Cancer After Breast Conserving Surgery Indicating Postoperative Radiotherapy With BoostArmsHypofractionation with simultaneous integrated boost
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 29 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

16 authors at 8 institutions in 1 country.

David KrugKlinik für Strahlentherapie, Universitätsklinikum Schleswig-Holstein, Arnold-Heller-Str. 3, 24105, Kiel, Germany. david.krug@uksh.de.ORCID http://orcid.org/0000-0001-8811-5416
René BaumannKlinik für Strahlentherapie, Universitätsklinikum Schleswig-Holstein, Arnold-Heller-Str. 3, 24105, Kiel, Germany.
Katja KrockenbergerZKS Lübeck, Universität zu Lübeck, Lübeck, Germany.
Reinhard VontheinInstitut für Medizinische Biometrie und Statistik, Universität zu Lübeck, Lübeck, Germany.
Andreas SchreiberPraxis für Strahlentherapie Dr. med. Andreas Schreiber, Dresden, Germany.
Alexander BoicevKlinik für Strahlentherapie und Radioonkologie, Heinrich-Braun-Klinikum Zwickau, Zwickau, Germany.
Florian WürschmidtRadiologische Allianz, Hamburg, Germany.
Evelyn WeinstrauchPraxis für Radioonkologie, Johanniter-Zentren für Medizinische Versorgung Stendal, Stendal, Germany.
Kirsten EilfPraxis für Strahlentherapie, Kiel, Germany.
Peter AndreasAbteilung für Strahlentherapie, Krankenhaus Buchholz, Buchholz in der Nordheide, Germany.
Ulrike HöllerMVZ Charité Vivantes, Berlin, Germany.
Stefan DingesKlinik für Strahlentherapie & Radioonkologie, Lüneburg, Germany.
Karen PiefelStrahlenzentrum Hamburg MVZ, Hamburg, Germany.
Jörg ZimmerPraxis für Strahlentherapie Dr. med. Andreas Schreiber, Dresden, Germany.
Kathrin DellasKlinik für Strahlentherapie, Universitätsklinikum Schleswig-Holstein, Arnold-Heller-Str. 3, 24105, Kiel, Germany.
Jürgen DunstKlinik für Strahlentherapie, Universitätsklinikum Schleswig-Holstein, Arnold-Heller-Str. 3, 24105, Kiel, Germany.
University Hospital Schleswig-Holstein · DEAmedon (Germany) · DEKlinik und Poliklinik für Strahlentherapie und Radioonkologie · DEUniversität Hamburg · DEUniversitätsklinik für Strahlentherapie · DEUniversity of Lübeck · DEVivantes Klinikum · DEVogtland-Klinik · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeWe report results of a multicenter prospective single-arm phase II trial (ARO-2013-04, NCT01948726) of moderately accelerated hypofractionated radiotherapy with a simultaneous integrated boost (SIB) in patients with breast cancer receiving adjuvant radiotherapy after breast-conserving surgery.

methodsThe eligibility criteria included unifocal breast cancer with an indication for adjuvant radiotherapy to the whole breast and boost radiotherapy to the tumor bed. The whole breast received a dose of 40 Gy and the tumor bed a total dose of 48 Gy in 16 fractions of 2.5 and 3 Gy, respectively. Radiotherapy could be given either as 3D conformal RT (3D-CRT) or as intensity-modulated radiotherapy (IMRT). The study was designed as a prospective single-arm trial to evaluate the acute toxicity of the treatment regimen. The study hypothesis was that the frequency of acute skin reaction grade ≥2 would be 20% or less.

resultsFrom November 2013 through July 2014, 149 patients were recruited from 12 participating centers. Six patients were excluded, leaving 143 patients for analysis. Eighty-four patients (58.7%) were treated with 3D-CRT and 59 (41.3%) with IMRT. Adherence to the treatment protocol was high. The rate of grade ≥2 skin toxicity was 14.7% (95% confidence interval 9.8-21.4%). The most frequent grade 3 toxicity (11%) was hot flashes.

conclusionThis study demonstrated low toxicity of and high treatment adherence to hypofractionated adjuvant radiotherapy with SIB in a multicenter prospective trial, although the primary hypothesis was not met.

Indexed as

Radiation Dose HypofractionationAntineoplastic Agents, HormonalBreast NeoplasmsChemotherapy, AdjuvantCombined Modality TherapyEstheticsFemaleHot FlashesHumansMastectomy, SegmentalPainPilot ProjectsProspective StudiesRadiodermatitisRadiotherapy, AdjuvantRadiotherapy, ConformalAntineoplastic Agents, HormonalAcute toxicityAdverse eventsIntensity modulated radiotherapyRadiation dermatitisTreatment compliance

Identifiers

PMID33001241
PMCPMC7801347
OpenAlexW3090425578

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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.