RT Journal Article
SR Electronic
T1 Predicting radiotherapy response, Toxicities and quality-of-life related functional outcomes in soft tissue sarcoma of the extremities (PredicT) using dose–volume constraints development: a study protocol
JF BMJ Open
JO BMJ Open
FD British Medical Journal Publishing Group
SP e083617
DO 10.1136/bmjopen-2023-083617
VO 14
IS 8
A1 Simões, Rita
A1 Gulliford, Sarah
A1 Seddon, Beatrice
A1 Dehbi, Hakim-Moulay
A1 Robinson, Martin
A1 Forsyth, Sharon
A1 Hughes, Ana
A1 Gaunt, Piers
A1 Nguyen, Thuy-Giang
A1 Elston, Stephanie
A1 Mohammed, Kabir
A1 Zaidi, Shane
A1 Miles, Elizabeth
A1 Hoskin, Peter
A1 Harrington, Kevin
A1 Miah, Aisha
YR 2024
UL http://bmjopen.bmj.com/content/14/8/e083617.abstract
AB Introduction Radiotherapy improves local tumour control in patients with soft tissue sarcoma of the extremities (STSE) but it also increases the probability of long-term toxicities such as tissue fibrosis, joint stiffness and lymphoedema. The use of radiation dose and volume thresholds, called dose constraints, may potentially reduce the development of toxicities in STSE. The aim of this study is to determine predictors of radiotherapy-related side effects for STSE.Methods and analysis Predicting radiotherapy response, Toxicities and quality-of-life related functional outcomes in soft tissue sarcoma of the extremities (PredicT) is a multicentre observational study comprising two cohorts (PredicT A and B). PredicT A, a retrospective analysis of the UK VorteX (NCT00423618) and IMRiS clinical trials (NCT02520128), is aimed at deriving a statistical model for development of dose–volume constraints. This model will use receiving operator characteristics and multivariate analysis to predict radiotherapy side effects and patient-reported outcomes. PredicT B, a prospective cohort study of 150 patients with STSE, is aimed at testing the validity of those dose–volume constraints. PredicT B is open and planned to complete recruitment by September 2024.Ethics and dissemination PredicT B has received ethical approval from North West - Liverpool Central Research Ethics Committee (20/NW/0267). Participants gave informed consent to participate in the study before taking part. We will disseminate our findings via publications, presentations, national and international conference meetings and engage with local charities.Trial registration number NCT05978024.