Predicting radiotherapy response and Toxicities in STSE (PredicT B)
Research type
Research Study
Full title
Predicting radiotherapy response, toxicities and quality of life related functional outcome in soft tissue sarcoma of the extremities: a prospective observational cohort study
IRAS ID
269876
Contact name
Aisha Miah
Contact email
Sponsor organisation
The Royal Marsden Hospital
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 6 months, 0 days
Research summary
Soft-tissue sarcoma of the extremities (STSE) are rare cancers, which originate in the muscles, nerves, cartilage and fatty tissues. The use of radiotherapy combined with surgery to remove these tumours improves the chances of curing patients. However, this can be at the cost of experiencing long-term permanent side-effects caused by radiotherapy, such as limb swelling, scar tissue formation, joint stiffness, all of which can lead to a deterioration of limb function and have a significant impact on a patient's quality-of-life.
This is a multicentre prospective cohort study, primarily aimed at reporting the frequency and intensity of radiotherapy side-effects of patients with STSE.
There is a potential that the long-term side-effects are reduced if the normal tissues are kept within safe limits; this involves using dose limits called dose-volume constraints. These constraints have not been well defined for STSE because of the rarity of the tumour type, and the lack of previous research in this area. The secondary objective of this study is therefore to test the validaty the dose-volume constraints derive as part of PredicT A study, utilising radiotherapy, toxicity and clinical data from the largest radiotherapy clinical trials for STSE (the VorteX and IMRiS trials).
Two sub-studies are proposed within the main study. Sub-studies participation is optional only for patients recruited at the Royal Marsden Hospital.
- 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 radiotherapy, post-operative radiotherapy or no radiotherapy. As well as, 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.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
20/NW/0267
Date of REC Opinion
15 Jul 2020
REC opinion
Further Information Favourable Opinion