Evidence map›Paper›PMID 32487184›Full record

Trial reportRadiation oncology (London, England)2020

Fatigue following radiotherapy of low-risk early breast cancer - a randomized controlled trial of intraoperative electron radiotherapy versus standard hypofractionated whole-breast radiotherapy: the COSMOPOLITAN trial (NCT03838419).

Tobias Forster, Cornelia Jäkel, Sati Akbaba, David Krug, Robert Krempien, Matthias Uhl, Matthias Felix Häfner, Laila König, Stefan Alexander Koerber, Semi Harrabi and 8 more

2 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Radiation oncology (London, England), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.6field-weighted citation impact, top 39% 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.

NCT03838419 nasuspendednot on this map

Intraoperative Electron Radiotherapy for Low-risk Early Breast Cancer

TypeinterventionalSponsorUniversity Hospital HeidelbergRan2019 to 2030Enrolled101ConditionsBreast CancerArmsintraoperative radiotherapy, whole breast irradiation
NCT04789889 naterminatednot on this mapstarted 2021, after this paper: background citation

Comparison of Satisfaction With Conserved Breast, Postoperative Complications and Tumor Control Between IORT and Postoperative Radiotherapy in Breast Conserving Surgery

TypeinterventionalSponsorXiangyun ZongRan2021 to 2025Enrolled80ConditionsQuality of LifeArmsintraoperative radiotherapy, postoperative radiotherapy
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 11 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. 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

18 authors at 8 institutions in 1 country.

Tobias ForsterDepartment of Radiation Oncology, Heidelberg University Hospital, Heidelberg University, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.
Cornelia JäkelDepartment of Radiation Oncology, Heidelberg University Hospital, Heidelberg University, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.
Sati AkbabaDepartment of Radiation Oncology, Heidelberg University Hospital, Heidelberg University, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.
David KrugDepartment of Radiation Oncology, Heidelberg University Hospital, Heidelberg University, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.
Robert KrempienDepartment of Radiation Oncology, Helios Hospital Berlin-Buch, Berlin, Germany.
Matthias UhlDepartment of Radiation Oncology, Heidelberg University Hospital, Heidelberg University, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.
Matthias Felix HäfnerDepartment of Radiation Oncology, Heidelberg University Hospital, Heidelberg University, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.
Laila KönigDepartment of Radiation Oncology, Heidelberg University Hospital, Heidelberg University, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.
Stefan Alexander KoerberDepartment of Radiation Oncology, Heidelberg University Hospital, Heidelberg University, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.
Semi HarrabiDepartment of Radiation Oncology, Heidelberg University Hospital, Heidelberg University, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.
Denise BernhardtDepartment of Radiation Oncology, Heidelberg University Hospital, Heidelberg University, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.
Rouven BehnischInstitute of Medical Biometry and Informatics, Heidelberg University, Heidelberg, Germany.
Johannes KrisamInstitute of Medical Biometry and Informatics, Heidelberg University, Heidelberg, Germany.
Andre HennigsDepartment of Gynecology and Obstetrics, Heidelberg University, 69115, Heidelberg, Germany.
Christof SohnDepartment of Gynecology and Obstetrics, Heidelberg University, 69115, Heidelberg, Germany.
Jörg HeilDepartment of Gynecology and Obstetrics, Heidelberg University, 69115, Heidelberg, Germany.
Jürgen DebusDepartment of Radiation Oncology, Heidelberg University Hospital, Heidelberg University, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.
Juliane Hörner-RieberDepartment of Radiation Oncology, Heidelberg University Hospital, Heidelberg University, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany. juliane.hoerner-rieber@med.uni-heidelberg.de.
Heidelberg University · DEHeidelberger Institut für Radioonkologie · DENational Center for Tumor Diseases · DEDeutschen Konsortium für Translationale Krebsforschung · DEHelios Hospital Berlin-Buch · DEUniversity Hospital Heidelberg · DEUniversity of Lübeck · DEZimmer Biomet (Germany) · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFatigue is one of the most common and distressing side-effects of breast cancer radiotherapy. According to current guidelines, accelerated partial breast irradiation (APBI) may be considered as an alternative treatment option for women with early-stage low-risk breast cancer. One method for APBI is single-dose intraoperative radiotherapy (IORT) applied directly to the tumor bed during breast conserving surgery (BCS). The COSMOPOLITAN trial therefore aims to analyze the intensity of fatigue following single-shot IORT with electrons (IOERT) compared to conventional hypofractionated whole breast irradiation (WBI) in low risk early breast cancer patients.

methodsThis trial is conducted as a multicenter, prospective, randomized, two-arm phase II study comparing the intensity of fatigue in early-stage breast cancer (cT1cN0cM0, tumor size < 2,5 cm, ER pos. Her2neu neg., age > 50 years) treated either with WBI or APBI after BCS. Secondary outcomes investigated are tumor control, overall survival (OS), disease-free survival (DFS), acute and chronic toxicity, quality of life (QoL) and cosmesis. A total of 202 patients will be randomized into two arms: Patients in arm A will receive WBI (40.05 Gy, 15 fractions) after surgical resection, while patients in arm B will receive IOERT (21 Gy to the 90%-isodose) during BCS. Fatigue will be assessed 12 weeks post surgery with the help of the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale. DISCUSSION: The present trial aims to evaluate treatment response to compare single-shot intraoperative electron APBI to conventional WBI following BCS in early-stage low risk breast cancer patients. Fatigue is selected as the primary, patient-reported endpoint due its major clinical relevance.

trial registrationThe study is prospectively registered on February 12th, 2019: Clinicaltrials.gov, NCT03838419. "Intraoperative Electron Radiotherapy for Low-risk Early Breast Cancer (COSMOPOLITAN)". STUDY STATUS: Ongoing study. Start of recruitment was December 2019.

Indexed as

AgedBreast NeoplasmsFatigueFemaleHumansIntraoperative PeriodMiddle AgedRadiation Dose HypofractionationRadiotherapy, AdjuvantRadiotherapy, High-EnergyRadiotherapy, Intensity-ModulatedResearch DesignBreast cancerFatigueIntraoperative electron radiotherapyRadiotherapyWhole-breast radiotherapy

Identifiers

PMID32487184
PMCPMC7268450
OpenAlexW3030922448

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.