Evidence map›Paper›PMID 35550036›Full record

ArticleBMC cancer2022

Neoadjuvant irradiation of extremity soft tissue sarcoma with ions (Extrem-ion): study protocol for a randomized phase II pilot trial.

D Brügemann, B Lehner, M Kieser, J Krisam, A Hommertgen, C Jaekel, S B Harrabi, K Herfarth, G Mechtesheimer, O Sedlaczek and 5 more

2 registry-linked trialsOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC cancer, 2022. 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.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.6field-weighted citation impact, top 32% 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.

NCT04946357 naactive not recruitingnot on this map

Neoadjuvant Irradiation of Extremity Soft Tissue Sarcoma With Ions

TypeinterventionalSponsorUniversity Hospital HeidelbergRan2021 to 2029Enrolled42ConditionsSoft Tissue SarcomaArmsProtons, carbon ions
NCT06264505 not yet recruitingnot on this mapstarted 2025, after this paper: background citation

Probing Participation in Soft Tissue Sarcoma Research: An Observational Study of Soft Tissue Sarcoma Clinical Trials

TypeobservationalSponsorPower Life Sciences Inc.Ran2025 to 2027Enrolled500ConditionsSoft Tissue Sarcoma
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 6 citations in OpenAlex.

  1. Review
  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

15 authors at 3 institutions in 1 country.

D BrügemannDepartment of Radiation Oncology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.
B LehnerCenter for Orthopedics, Trauma Surgery and Paraplegiology, University of Heidelberg, Heidelberg, Germany.
M KieserInstitute for Medical Biometry, University of Heidelberg, Heidelberg, Germany.
J KrisamInstitute for Medical Biometry, University of Heidelberg, Heidelberg, Germany.
A HommertgenDepartment of Radiation Oncology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.
C JaekelDepartment of Radiation Oncology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.
S B HarrabiDepartment of Radiation Oncology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.
K HerfarthDepartment of Radiation Oncology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.
G MechtesheimerInstitute of Pathology, University of Heidelberg, Heidelberg, Germany.
O SedlaczekDepartment of Radiology, University of Heidelberg, Heidelberg, Germany.
G EgererDepartment of Hematology, Oncology and Rheumatology, Heidelberg University, Heidelberg, Germany.
A GeisbüschCenter for Orthopedics, Trauma Surgery and Paraplegiology, University of Heidelberg, Heidelberg, Germany.
M UhlDepartment of Radiation Oncology, Klinikum Ludwigshafen, Ludwigshafen, Germany.
J DebusDepartment of Radiation Oncology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.
K SeidensaalDepartment of Radiation Oncology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany. katharina.seidensaal@med.uni-heidelberg.de.ORCID http://orcid.org/0000-0001-5969-6426
Heidelberg University · DEGerman Cancer Research Center · DEKlinikum Ludwigshafen · DE

Funding

Deutsche Forschungsgemeinschaft UH 270/2-1; AOBJ: 674373
6 · The paper itself

Abstract

backgroundThe standard of care treatment for soft tissue sarcoma of the extremities is a wide resection in combination with pre- or postoperative radiotherapy with high local control rates, sparing patients the necessity of amputation without compromising on overall survival rates. The currently preferred timing of radiotherapy is under debate. Albeit having higher rates of acute wound complications, late side effects like fibrosis, joint stiffness or edema are less frequent in preoperative compared to postoperative radiotherapy. This can be explained in smaller treatment volumes and a lower dose in the preoperative setting. Particles allow better sparing of surrounding tissues at risk, and carbon ions additionally offer biologic advantages and are preferred in less radiosensitive tumors. Hypofractionation allows for a significantly shorter treatment duration.

methodsExtrem-ion is a prospective, randomized, monocentric phase II trial. Patients with resectable or marginally resectable, histologically confirmed soft tissue sarcoma of the extremities will be randomized between neoadjuvant proton or neoadjuvant carbon ion radiotherapy in active scanning beam application technique (39 Gy [relative biological effectiveness, RBE] in 13 fractions [5-6 fractions per week] in each arm). The primary objective is the proportion of therapies without wound healing disorder the first 120 days after surgery or discontinuation of treatment for any reason related to the treatment. The secondary endpoints of the study consist of local control, local progression-free survival, disease-free survival, overall survival, and quality of life. DISCUSSION: The aim of this study is to confirm that hypofractionated, preoperative radiotherapy is safe and feasible. The potential for reduced toxicity by the utilization of particle therapy is the rational of this trial. A subsequent randomized phase III trial will compare the hypofractionated proton and carbon ion irradiation in regards to local control.

trial registrationClinicalTrials.gov Identifier: NCT04946357 ; Retrospectively registered June 30, 2021.

Indexed as

SarcomaSoft Tissue NeoplasmsCarbonClinical Trials, Phase II as TopicExtremitiesHumansIonsNeoadjuvant TherapyPilot ProjectsProspective StudiesProtonsQuality of LifeRandomized Controlled Trials as TopicCarbonIonsProtonsCarbon ion therapyExtremity soft tissue sarcomaHeavy ion therapyHypofractionationIrradiationProton therapyRandomized trial

Identifiers

PMID35550036
PMCPMC9097299
OpenAlexW4280511732

What OpenQuestion holds

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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.