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

NCT05978024 | Recruiting

• 1 other identifier: CCR5166
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 3

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). 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

Soft Tissue Sarcoma of the Extremities

Outcome Measures

Primary Outcomes (1)

• The incidence of any RTOG grade ≥ 2 toxicities following treatment for STSE at 24 months

  The primary objective is to report the frequency and intensity of radiotherapy side-effects in STSE.

  24 Months

Secondary Outcomes (7)

• 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.

  24 Months

• To report frequencies and proportions of radiotherapy-induced late toxicities

  24 Months

• To determine the time to developing early and late side-effects.

  24 Months

• To determine radiological response rates to radiotherapy and where applicable chemo-radiotherapy for STSE of different histological subtypes.

  24 Months

• To determine histological response rates to radiotherapy and where applicable chemo-radiotherapy for STSE of different histological subtypes.

  24 Months

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population to be enrolled in this observational study will have had been diagnosed with STSE and referred to receive a course of radiotherapy either in the primary, palliative, pre-operative or post-operative settings.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead

Study Sites (3)

Addenbrooke's Hospital

Cambridge, CB2 0QQ, United Kingdom

RECRUITING

The Royal Marsden NHS Foundation Trust

London, SW3 6JJ, United Kingdom

RECRUITING

University College London

London, WC1E 6BT, United Kingdom

RECRUITING

Related Publications (1)

• Simoes 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 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

* Tumour tissue for histopathological markers, immune function and DNA damage response from the area receiving radiotherapy (both biopsies and surgical resection specimens) * Blood samples for immune function analysis (Up to 50 ml at each time point).

Study Officials

• Aisha Miah

  The Royal Marsden Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thuy-Giang Nguyen

CONTACT

02078118090; Thuy-Giang.Nguyen@rmh.nhs.uk

Stephanie Elston

CONTACT

02078118395; stephanie.elston@rmh.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2023
• First Posted: August 7, 2023
• Study Start: April 16, 2021
• Primary Completion: July 30, 2024
• Study Completion (Estimated): July 30, 2026
• Last Updated: August 7, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)