Actively Recruiting

Age: 16Years +
All Genders
Healthy Volunteers
NCT05978024

Predicting Radiotherapy Response and Toxicities in Soft Tissue Sarcoma of the Extremities - Cohort B

Led by Royal Marsden NHS Foundation Trust · Updated on 2023-08-07

150

Participants Needed

3

Research Sites

275 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a multicentre prospective cohort study, primarily aimed at reporting the frequency and intensity of radiotherapy side-effects of patients with soft tissues sarcoma of the extremities (STSE). Two sub-studies are proposed within this study: * MRI radiation response assessment Aimed at establishing whether changes in median apparent diffusion coefficients (ADC) are predictive of pre-operative STSE response measured using histopathology. * Biomarker development and Immune mediators associated with radiotherapy Aimed at establishing prognostic markers which may refine selection of cases for pre-operative, palliative or no radiotherapy. Also, aimed at determining if radiotherapy stimulates the tumour microenvironment, resulting in measurable change in anti-tumour immunity and if certain subtypes could potentially benefit from the addition of immunotherapy with radiation. Patients participation in the sub-studies is optional.

CONDITIONS

Official Title

Predicting Radiotherapy Response and Toxicities in Soft Tissue Sarcoma of the Extremities - Cohort B

Who Can Participate

Age: 16Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Histopathological diagnosis of soft tissue sarcoma of the upper or lower limb or limb girdle
  • Patients receiving pre-operative, post-operative, or palliative radiotherapy
  • Radiotherapy planned according to local protocols; neoadjuvant chemotherapy allowed
  • WHO performance status between 0 and 2
  • Age 16 years or older
  • Fit enough to undergo radiotherapy and willing to attend follow-up visits for two years
  • Female patients of child-bearing potential and male patients with partners of child-bearing potential must agree to use adequate contraception during treatment and for 3 months after
  • Able to give written informed consent
Not Eligible

You will not qualify if you...

  • Previous radiotherapy to the same site
  • Pregnancy
  • Concurrent or previous malignancy that could affect assessment of study endpoints

AI-Screening

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Trial Site Locations

Total: 3 locations

1

Addenbrooke's Hospital

Cambridge, United Kingdom, CB2 0QQ

Actively Recruiting

2

The Royal Marsden NHS Foundation Trust

London, United Kingdom, SW3 6JJ

Actively Recruiting

3

University College London

London, United Kingdom, WC1E 6BT

Actively Recruiting

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Research Team

T

Thuy-Giang Nguyen

CONTACT

S

Stephanie Elston

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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