Status:
RECRUITING
Predicting Radiotherapy Response and Toxicities in Soft Tissue Sarcoma of the Extremities - Cohort B
Lead Sponsor:
Royal Marsden NHS Foundation Trust
Conditions:
Soft Tissue Sarcoma of the Extremities
Eligibility:
All Genders
16+ years
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). ...
Detailed Description
This is a multicentre prospective cohort study, primarily aimed at validating the dose-volume parameters identified in the analyses of the VorteX and IMRiS trials datasets. • Delineation of healthy t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 16 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 30 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05978024
Start Date
April 16 2021
End Date
July 30 2026
Last Update
August 7 2023
Active Locations (3)
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1
Addenbrooke's Hospital
Cambridge, United Kingdom, CB2 0QQ
2
The Royal Marsden NHS Foundation Trust
London, United Kingdom, SW3 6JJ
3
University College London
London, United Kingdom, WC1E 6BT