Predicting Radiotherapy Response and Toxicities in Soft Tissue Sarcoma of the Extremities
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
| Condition(s) | Soft Tissue Sarcoma of the Extremities |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | 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 |
| Who can participate | Inclusion Criteria: * Histopathological diagnosis of soft tissue sarcoma of the upper or lower limb or limb girdle; * Patients receiving pre-operative (neo-adjuvant), post-operative (adjuvant) or palliative radiotherapy; * Patients receiving radiotherapy planned as per local protocols (neoadjuvant chemotherapy will be allowed). Neoadjuvant chemotherapy patients may be approached as they commence chemotherapy; * WHO performance status 0-2; * Aged ≥16 years; * Patients fit enough to undergo radiotherapy treatment and willing to attend follow up visits, during two years; * Female patients of child-bearing potential and male patients with partners of child-bearing potential must agree to use adequate contraception methods, which must be continued for 3 months after completion of treatment; * C |
| Ages | 16 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Royal Marsden NHS Foundation Trust |
| Locations | Cambridge, United Kingdom; London, United Kingdom; London, United Kingdom |
| Start date | 2021-04-16 |
| NCT ID | NCT05978024 |
| Official listing | https://clinicaltrials.gov/study/NCT05978024 |