NCT05978024 Predicting Radiotherapy Response and Toxicities in Soft Tissue Sarcoma of the Extremities - Cohort B
| NCT ID | NCT05978024 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Royal Marsden NHS Foundation Trust |
| Condition | Soft Tissue Sarcoma of the Extremities |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2021-04-16 |
| Primary Completion | 2024-07-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2021-04-16 with a primary completion date of 2024-07-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 subtypes could potentially benefit from the addition of immunotherapy with radiation. Patients participation in the sub-studies is optional.
Eligibility Criteria
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; * Capable of giving written informed consent. Exclusion Criteria: * Previous radiotherapy to the same site; * Pregnancy; * Patients with concurrent or previous malignancy that could compromise assessment of primary and secondary endpoints of the trial.
Contact & Investigator
Aisha Miah
PRINCIPAL INVESTIGATOR
The Royal Marsden Hospital
Frequently Asked Questions
Who can join the NCT05978024 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, studying Soft Tissue Sarcoma of the Extremities. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05978024 currently recruiting?
Yes, NCT05978024 is actively recruiting participants. Contact the research team at Thuy-Giang.Nguyen@rmh.nhs.uk for enrollment information.
Where is the NCT05978024 trial being conducted?
This trial is being conducted at Cambridge, United Kingdom, London, United Kingdom, London, United Kingdom.
Who is sponsoring the NCT05978024 clinical trial?
NCT05978024 is sponsored by Royal Marsden NHS Foundation Trust. The principal investigator is Aisha Miah at The Royal Marsden Hospital. The trial plans to enroll 150 participants.