Evidence map›Paper›PMID 41310692›Full record

Trial reportRadiation oncology (London, England)2025

Hypofractionated radiotherapy with hyperthermia in radiation-associated and in-volume recurrent soft tissue sarcomas of the extremities and trunk wall: results of a proof-of-concept prospective trial.

Konrad Zasadziński, Aneta Borkowska, Dorota Kopeć, Maria Telejko, Piotr Rutkowski, Mateusz Jacek Spałek

Registry-linked trialAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Radiation oncology (London, England), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04398095 (Hyperthermia and Radiotherapy in the Treatment for In-field Recurrent and Radiation-induced Soft Tissue and Bone Sarcomas), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

NCT04398095 nacompletednot on this map

Hyperthermia and Radiotherapy in the Treatment for In-field Recurrent and Radiation-induced Soft Tissue and Bone Sarcomas

TypeinterventionalSponsorMaria Sklodowska-Curie National Research Institute of OncologyRan2019 to 2023Enrolled20ConditionsRadiation Induced Neoplasms, Radiation-Induced Cancer, Recurrent Sarcoma, Recurrent Soft Tissue SarcomaArmsHypofractionated radiotherapy, Hyperthermia, Hypofractionated radiotherapy with boost
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
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

6 authors.

Konrad ZasadzińskiDepartment of Radiotherapy I, Maria Skłodowska-Curie National Research Institute of Oncology, Roentgena 5, Warsaw, 02-781, Poland.
Aneta BorkowskaDepartment of Radiotherapy I, Maria Skłodowska-Curie National Research Institute of Oncology, Roentgena 5, Warsaw, 02-781, Poland.
Dorota KopećDepartment of Medical Physics, Maria Skłodowska-Curie National Research Institute of Oncology, Warsaw, Poland.
Maria TelejkoDepartment of Radiotherapy I, Maria Skłodowska-Curie National Research Institute of Oncology, Roentgena 5, Warsaw, 02-781, Poland.
Piotr RutkowskiDepartment of Soft Tissue/Bone Sarcoma and Melanoma, Maria Skłodowska- Curie National Research Institute of Oncology, Roentgena 5, Warsaw, 02-781, Poland.
Mateusz Jacek SpałekDepartment of Radiotherapy I, Maria Skłodowska-Curie National Research Institute of Oncology, Roentgena 5, Warsaw, 02-781, Poland. mateusz.spalek@nio.gov.pl.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveRadiation-associated sarcomas (RAS) and in-volume recurrent sarcomas (IRS) are significant therapeutic challenges due to prior radiotherapy (RT) exposure and the risks associated with re-irradiation. The aim of this study was to evaluate the safety and efficacy of moderately hypofractionated RT combined with locoregional hyperthermia (HT) in patients with RAS/IRS.

methodsA prospective, proof-of-concept, single-arm, phase II clinical trial (NCT04398095) was conducted in which 20 patients with locally advanced RAS/IRS of the extremities and trunk wall were enrolled. Treatment consisted of RT at 36 Gy in 12 fractions over three weeks, combined with at least weekly HT sessions. Unresectable tumors received an integrated boost to 42 Gy. The primary endpoint was grade 3 or higher late toxicity according to the Common Terminology Criteria for Adverse Events version 5.0 at 18 months, while secondary endpoints included local control, progression-free survival (PFS), and cancer-specific survival (CSS).

resultsMedian follow-up was 48.9 months. No patient developed grade ≥ 3 late toxicity. Seven patients (35%) experienced local progression. No local progression was observed in the unresectable group treated with integrated boost. All tumors showed radiologic response (partial or stable disease). We observed up to 10% viable tumor cells in the postoperative specimens of five of the 12 patients who underwent surgery. One- and two-year PFS were 70% and 45%, respectively; CSS was 95% and 90%, respectively.

conclusionsModerately hypofractionated RT with HT is a safe approach for RAS/IRS reirradiation. Dose escalation may improve local control and warrants further investigation in larger studies.

Indexed as

ExtremitiesHyperthermia, InducedNeoplasm Recurrence, LocalNeoplasms, Radiation-InducedRadiation Dose HypofractionationSarcomaAdultAgedCombined Modality TherapyFemaleHumansMaleMiddle AgedPrognosisProof of Concept StudyProspective StudiesHypofractionationLate toxicityNeoadjuvant treatmentPreoperative radiotherapyRadiation-associated sarcomaRecurrent sarcomaReirradiation

Identifiers

PMID41310692
PMCPMC12659549

What Socratic holds

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LicenceCC BY-NC-ND
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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 Socratic graph.