At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Not specified by the sponsor
- How long the study runs
- Study runs about 63 months (dates as stated)
- About the drug or intervention
- Not specified by the sponsor
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Observing health over time
- Ages
- 16 Years and over
- Who
- All
- Number of participants
- 150
- Started
- 2021-04-16
- Last checked
- 2023-07
Plain English Summary
What is this study?
- • Testing a new treatment for soft tissue sarcoma of the extremities
- • Clinical study - 150 participants
- • 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)
Who can take part?
- • Ages 16 Years and over
- • Diagnosed with soft tissue sarcoma of the extremities
Where?
- • Cambridge - Addenbrooke's Hospital
- • London - The Royal Marsden NHS Foundation Trust
- • London - University College London
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
This is a multicentre prospective cohort study, primarily aimed at validating the dose-volume parameters identified in the analyses of the VorteX and IMRiS trials datasets. • Delineation of healthy tissues Pre-defined outlining guidelines of normal tissues as bones, muscle compartments, joints, lymph drainage basins and subcutaneous tissue from Predict A will be delineated in radiotherapy planning computed tomography (CT) images. All cases will be delineated by a single observer (Rita Simoes). Verification of all outlines will be carried out by Dr Aisha Miah (clinical supervisor). • Dose-volume constraints validity testing Patients will be treated as per local protocol treatment technique. Radiotherapy, clinical and toxicities data will be collected, with no new intervention on the treatment. Patients enrolled will receive standard radiation prescription doses as described below: * Pre-operative radiotherapy- 50 Gy in 25 fractions equivalent (pre-operative radiotherapy). Where appropriate hypo-fractionated schedules as per institutional guidelines can considered: eg. 25 Gy/ 5 daily fractions. In myxoid liposarcomas, 36 Gy in 18 fractions can be considered where suitable; * Post-operative radiotherapy- 60 Gy in 30 fractions or 66 Gy in 33 fractions (positive resection margins); alternative hypo-fractionated schedules as per institutional guidelines can be considered; * Palliative radiotherapy- 30-36 Gy in 10-12 daily fractions, 40-45 Gy in 15 fractions, 30-36 Gy in 5-6 once weekly fractions or 25 Gy in 5 daily fractions. Toxicity will be assessed with the TESS and RTOG scoring instruments and Stern score for lymphoedema. Patients enrolled in the study will fill in a specific quality-of-life questionnaire to assess quality of life related functional outcomes following treatment for STSE. This questionnaire is based on validated questions for assessing quality-of-life. Patients will be followed up at 3, 6, 12, 18, and 24 months post-radiotherapy.
How this trial compares with your answers
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What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 16 Years and over
- Who can join: All genders
What the study is looking for
- ✓Histopathological diagnosis of soft tissue sarcoma of the upper or lower limb or limb girdle;
- ✓Patients receiving pre-operative (neo-after surgery), post-operative (after surgery) or palliative radiotherapy;
- ✓Patients receiving radiotherapy planned as per local protocols (before surgery drug treatment will be allowed)....
- ✓WHO performance status 0-2;
- ✓Aged ≥16 years;
Who cannot take part
- ✗Previous radiotherapy to the same site;
- ✗Pregnancy;
- ✗Patients with concurrent or previous cancer that could compromise assessment of primary and secondary endpoints...
See the full criteria
Where Is This Study? (3 UK sites)
Addenbrooke's Hospital
Cambridge CB2 0QQ, United Kingdom
The Royal Marsden NHS Foundation Trust
London SW3 6JJ, United Kingdom
University College London
London WC1E 6BT, United Kingdom
How to Get in Touch
Thuy-Giang Nguyen
Sponsor contactCONTACT
Stephanie Elston
Sponsor contactCONTACT