Evidence map›Paper›PMID 39122389›Full record

ArticleBMJ open2024

Predicting radiotherapy response, Toxicities and quality-of-life related functional outcomes in soft tissue sarcoma of the extremities (PredicT) using dose-volume constraints development: a study protocol.

Rita Simões, Sarah Gulliford, Beatrice Seddon, Hakim-Moulay Dehbi, Martin Robinson, Sharon Forsyth, Ana Hughes, Piers Gaunt, Thuy-Giang Nguyen, Stephanie Elston and 6 more

3 registry-linked trialsAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT00423618 phase3completednot on this map

Randomised Trial of Post-Operative Radiotherapy Given to Adult Patients With Extremity Soft Tissue Sarcoma [VORTEX]

TypeinterventionalSponsorSheffield Teaching Hospitals NHS Foundation TrustRan2006 to 2018Enrolled216ConditionsSarcomaArmsradiotherapy
NCT02520128 nacompletednot on this map

A Phase II Study of Intensity Modulated Radiotherapy (IMRT) for Patients With Primary Bone and Soft Tissue Sarcoma

TypeinterventionalSponsorUniversity College, LondonRan2016 to 2020Enrolled191ConditionsSoft Tissue Sarcoma, Adult, Ewing Sarcoma, Bone Sarcoma, ChordomaArmsIntensity modulated radiotherapy (IMRT)
NCT05978024 unknown statusnot on this map

Predicting Radiotherapy Response, Toxicities and Quality of Life Related Functional Outcome in Soft Tissue Sarcoma of the Extremities: a Prospective Observational Cohort Study

TypeobservationalSponsorRoyal Marsden NHS Foundation TrustRan2021 to 2026Enrolled150ConditionsSoft Tissue Sarcoma of the Extremities
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. 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

16 authors.

Rita SimõesInstitute of Cancer Research, London, UK rita.simoes@nhs.net.ORCID 0000-0003-3874-3128
Sarah GullifordUniversity College London Hospital NHS Foundation Trust, London, UK.
Beatrice SeddonUniversity College London Hospital NHS Foundation Trust, London, UK.
Hakim-Moulay DehbiInstitute of Clinical Trials and Methodology, University College London, London, UK.
Martin RobinsonUniversity of Sheffield, Sheffield, UK.
Sharon ForsythCancer Research UK & UCL Cancer Trials Centre, University College London, London, UK.
Ana HughesCRUK Clinical Trials Unit, University of Birmingham, Birmingham, UK.
Piers GauntCRUK Clinical Trials Unit, University of Birmingham, Birmingham, UK.
Thuy-Giang NguyenRoyal Marsden Hospital, London, UK.
Stephanie ElstonRoyal Marsden Hospital, London, UK.
Kabir MohammedRoyal Marsden Hospital, London, UK.
Shane ZaidiInstitute of Cancer Research, London, UK.
Elizabeth MilesNational Radiotherapy Trials Quality Assurance Group, Mount Vernon Hospital, Northwood, UK.
Peter HoskinUniversity of Manchester, The Victoria University of Manchester Campus, Manchester, UK.
Kevin HarringtonTargeted Therapy Team, The Institute of Cancer Research, London, UK.
Aisha MiahInstitute of Cancer Research, London, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionRadiotherapy improves local tumour control in patients with soft tissue sarcoma of the extremities (STSE) but it also increases the probability of long-term toxicities such as tissue fibrosis, joint stiffness and lymphoedema. The use of radiation dose and volume thresholds, called dose constraints, may potentially reduce the development of toxicities in STSE. The aim of this study is to determine predictors of radiotherapy-related side effects for STSE. METHODS AND ANALYSIS: Predicting radiotherapy response, Toxicities and quality-of-life related functional outcomes in soft tissue sarcoma of the extremities (PredicT) is a multicentre observational study comprising two cohorts (PredicT A and B). PredicT A, a retrospective analysis of the UK VorteX (NCT00423618) and IMRiS clinical trials (NCT02520128), is aimed at deriving a statistical model for development of dose-volume constraints. This model will use receiving operator characteristics and multivariate analysis to predict radiotherapy side effects and patient-reported outcomes. PredicT B, a prospective cohort study of 150 patients with STSE, is aimed at testing the validity of those dose-volume constraints. PredicT B is open and planned to complete recruitment by September 2024. ETHICS AND DISSEMINATION: PredicT B has received ethical approval from North West - Liverpool Central Research Ethics Committee (20/NW/0267). Participants gave informed consent to participate in the study before taking part. We will disseminate our findings via publications, presentations, national and international conference meetings and engage with local charities. TRIAL REGISTRATION NUMBER: NCT05978024.

Indexed as

ExtremitiesQuality of LifeSarcomaHumansMaleMulticenter Studies as TopicObservational Studies as TopicProspective StudiesRadiotherapy DosageRetrospective StudiesSoft Tissue NeoplasmsTreatment Outcomeoncologyradiation oncologyradiotherapysarcoma

Identifiers

PMID39122389
PMCPMC11331914

What OpenQuestion holds

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LicenceCC BY-NC
Read underepoch 390

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.