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RECRUITINGOBSERVATIONAL

Predicting Radiotherapy Response and Toxicities in Soft Tissue Sarcoma of the Extremities - Cohort B

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Locations (3)

Addenbrooke's Hospital
Cambridge, United Kingdom
The Royal Marsden NHS Foundation Trust
London, United Kingdom
University College London
London, United Kingdom