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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07432932

Acronym

PANTHR-S

Enrollment

800

Registered

2026-02-25

Start date

2021-11-19

Completion date

2028-06-30

Last updated

2026-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Angiosarcoma, Leiomyosarcoma (LMS), Liposarcoma, Liposarcoma, Dedifferentiated, Retroperitoneal Sarcoma, Sarcoma, Sarcoma, Leiomyo-, Adult, Sarcoma, Synovial, Adult, Soft Tissue Sarcoma Adult, Soft Tissue Sarcoma of the Limb, Soft Tissue Sarcoma of the Trunk and Extremities, Soft Tissue Sarcoma (STS)

Keywords

PANTHRS, PANTHRS-S, Sarcoma Accelerator

Brief 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.

Detailed description

This is a multi-centre collaborative study across four countries which aims to accelerate precision medicine approaches for neoadjuvant therapy in high risk sarcomas. The study will include both prospective and retrospective patient identification and inclusion from two cohorts; patients who advanced to surgery alone or received surgery and NCT. The participating local centres will continue pre-approved established data and tissue collection processes. Collaboration with external sites will allow the recruitment of a larger cohort of patients to be included in analyses. Patients will be recruited for the study from each of the following five centres: The Royal Marsden Hospital, The Beatson West of Scotland Centre Glasgow, Birmingham NHS Trust, Fondazione IRCCS Istituto Nazionale dei Tumori and Hospital Universitario Virgen del Rocio/Instituto de Biomedicina de Sevilla. Translational research analysis will be undertaken at all three centres. Pseudonymised clinical data and tissue samples from each centre will be sent to the centre responsible for the specific component of the project. The transfer of material and data will be undertaken in accordance with Human Tissue Authority (HTA) regulation, and appropriate MTAs will be put in place prior to the transfer of any tissue between sites. A data protection checklist will also be completed and reviewed by the information governance team of each institution to ensure all pseudonymised data shared by collaborating sites is dealt with appropriately and adheres to the responsibilities of each institution relating to patient confidentiality and appropriate data handling practices.

Interventions

OTHERObservational Translational Study

Cohort study aimed at developing a stratified medicine approach for personalised neoadjuvant chemotherapy (NCT)

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

-Prior invasive malignancy in last 5 years, low risk malignancies in the last 5 years may be reviewed by the PI. * Known additional malignancy that is progressing or requires active treatment * Metastatic disease not amenable to curative intent local therapy * Any active uncontrolled medical conditions

Design outcomes

Primary

Measure	Time frame
Identify a difference in expression profiles, using proteomics, genomics, epigenomics, in tissue samples obtained pre- and post-NCT and post-surgery alone	Through study completion, average 4 years
Develop an understanding of radiomic profiles for patients treated with NCT.	Through study completion, average 4 years
Develop an electronic STS Tissue Atlas for 5 high risk subtypes.	Through study completion, average 4 years
Develop and characterize patient derived models to investigate biology of high-risk sarcomas and directly test predicted therapeutic interventions	Through study completion, average 4 years
Develop a nomogram app to predict benefit of NCT and predict risk of recurrence.	Through study completion, average 4 years

Secondary

Measure	Time frame
To assess whether there is a difference in metastases-free survival (MFS), recurrence free survival (RFS) and overall survival (OS) between patients with high risk STS who receive NCT compared to those who do not receive NCT	Through study completion, average 4 years

Countries

United Kingdom

Contacts

CONTACTStephanie Elston, MSc

PANTHRS.Trial@rmh.nhs.uk02073528171

CONTACTThuy-Giang Nguyen, BSc