Predicting radiotherapy response and side effects in soft tissue sarcoma patients

Predicting Radiotherapy Response, Toxicities and Quality of Life Related Functional Outcome in Soft Tissue Sarcoma of the Extremities: a Prospective Observational Cohort Study

This study looks at how well radiotherapy works and what side effects it causes in patients with soft tissue sarcoma in their arms or legs, while also trying to find ways to predict these effects.

Quick facts

• Study type: Observational
• Enrollment: 150 (estimated)
• Ages: 16 Years and up
• Sex: All
• Sponsor: Royal Marsden NHS Foundation Trust (other)
• Drugs / interventions: chemotherapy, immunotherapy, radiation
• Locations: 3 sites (Cambridge and 2 other locations)
• Trial ID: NCT05978024 on ClinicalTrials.gov

What this trial studies

This multicentre prospective cohort study aims to report the frequency and intensity of radiotherapy side effects in patients with soft tissue sarcoma of the extremities. It includes two sub-studies: one assessing MRI radiation response to predict pre-operative response using histopathology, and another focusing on developing biomarkers and immune mediators associated with radiotherapy. The study will collect data on radiotherapy, clinical outcomes, and toxicities without introducing new interventions, as patients will receive standard radiation doses based on local protocols. Participation in the sub-studies is optional for enrolled patients.

Who should consider this trial

Good fit: Ideal candidates include patients aged 16 and older with a histopathological diagnosis of soft tissue sarcoma of the upper or lower limb who are receiving radiotherapy.

Not a fit: Patients with previous radiotherapy to the same site or those who are pregnant may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the understanding of radiotherapy effects and improve treatment strategies for patients with soft tissue sarcoma.

How similar studies have performed: Other studies have shown success in similar approaches, particularly in validating dose-volume parameters and assessing radiotherapy effects.

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.

Where this trial is running

Cambridge and 2 other locations

• Addenbrooke's Hospital — Cambridge, United Kingdom (RECRUITING)
• The Royal Marsden NHS Foundation Trust — London, United Kingdom (RECRUITING)
• University College London — London, United Kingdom (RECRUITING)

Study contacts

• Principal investigator: Aisha Miah — The Royal Marsden Hospital
• Study coordinator: Thuy-Giang Nguyen

Conditions: Soft Tissue Sarcoma of the Extremities