Actively Recruiting
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
Eligibility Criteria
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
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
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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