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Precision Medicine Approaches for Neoadjuvant Therapy in High-risk Sarcoma Patients

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY

This is a cohort study aimed at developing a stratified medicine approach for personalised neoadjuvant chemotherapy (NCT) in high-risk soft tissue sarcoma (STS) patients with dedifferentiated liposarcoma (DDLPS), leiomyosarcoma (LMS), synovial sarcoma (SS), vascular sarcomas, malignant peripheral nerve sheath tumour (MPNST) or other subtypes. It comprises of both retrospective and prospective tissue collection from patients advancing directly to surgery (control group) and patients receiving NCT and surgery.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Written informed consent for the prospective cohort

‣ Histopathological diagnosis of high-risk soft tissue sarcoma and one of the following subtypes: DDLPS, LMS, SS, vascular sarcomas or MPNST. Other subtypes may be included with PI approval.

⁃ High-risk sarcoma definition:

• Greater than 5cm or Grade 3

∙ Deep anatomic location

⁃ Have disease amenable to biopsy

‣ o Patients who are not amenable to repeat biopsy at baseline can be reviewed with the local site PI for consideration of inclusion to the study

⁃ Resectable tumour

⁃ Measurable disease by RECIST 1.1

⁃ Aged ≥ 18 years

⁃ WHO performance status 0-2

⁃ For patients receiving NCT, medically fit enough, with adequate organ function, to undergo neoadjuvant chemotherapy

⁃ Patients medically fit enough to undergo surgical resection

⁃ Capable of giving written informed consent (for prospective cohort) and comply with the study schedule

⁃ Patients may also participate in the STRASS 2 trial

Locations
Other Locations
United Kingdom
The Royal Marsden Hospital
RECRUITING
London
Contact Information
Primary
Stephanie Elston, MSc
PANTHRS.Trial@rmh.nhs.uk
02073528171
Backup
Thuy-Giang Nguyen, BSc
PANTHRS.Trial@rmh.nhs.uk
02073528171
Time Frame
Start Date: 2021-11-19
Estimated Completion Date: 2028-06-30
Participants
Target number of participants: 800
Treatments
Prospective
Prospective observational cohort study: a cohort of patients advancing directly to surgery (Control group) and Prospective cohort receiving neo-adjuvant chemotherapy. Prospectively enrolled patients with STS, tissue samples pre-chemotherapy and from surgical resection will undergo epigenetic, proteomic and genomic profiling to define the biology at two distinct time points.
Retrospective
Retrospective cohort study: a cohort of patients who advanced directly to surgery (Control group) and a cohort treated with NCT.
Sponsors
Collaborators: University Hospital Birmingham, Freeman Hospital, UK, the Fundación Científica de la Asociación Española Contra el Cáncer, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, NHS Greater Glasgow and Clyde, Hospitales Universitarios Virgen del Rocío, University of Birmingham, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz, University of Edinburgh, Associazione Italiana per la Ricerca sul Cancro, Andalusian Network for Design and Translation of Advanced Therapies, Liverpool Hospital, Cancer Research UK, Instituto de Biomedicina de Sevilla, The Clatterbridge Cancer Centre NHS Foundation Trust, Institute of Cancer Research, United Kingdom
Leads: Royal Marsden NHS Foundation Trust

This content was sourced from clinicaltrials.gov