Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Soft Tissue Sarcoma of the Extremities | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- The incidence of any RTOG grade ≥ 2 toxicities following treatment for STSE at 24 months
- timeFrame
- 24 Months
- description
- The primary objective is to report the frequency and intensity of radiotherapy side-effects in STSE.
Secondary outcomes (7)
- measure
- The ability of the fitted model from dose-volume constraints from PredicT A (IMRiS and Vortex analysis) to correctly predict the incidence of grade 2+ among PredicT B patients.
- timeFrame
- 24 Months
- description
- To report the differences in experienced by patients with STSE for whom dose-volume constraints were below or exceeded. Binary logistic regression will be used to quantify the differences using odds ratios (OR) from the fitted models. Univariate logistic regression models will be fitted to predict for the parameters relevant to toxicity grades in the RTOG, Stern's and TESS scales. ORs for each of the parameters will be used to judge for significant differences between the groups. There is no plan to fit multivariate model.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDSimoes R, Gulliford S, Seddon B, Dehbi HM, Robinson M, Forsyth S, Hughes A, Gaunt P, Nguyen TG, Elston S, Mohammed K, Zaidi S, Miles E, Hoskin P, Harrington K, Miah A. 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. BMJ Open. 2024 Aug 9;14(8):e083617. doi: 10.1136/bmjopen-2023-083617. PMID 39122389