Precision Medicine Approaches for Neoadjuvant Therapy in High-risk Sarcoma Patients (PANTHR-S)

February 18, 2026 updated by: Royal Marsden NHS Foundation Trust
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with one of DDLPS, LMS, SS, vascular sarcomas or MPNST either advancing directly to surgery or receiving neoadjuvant chemotherapy and surgery

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: Observational Translational Study
Cohort study aimed at developing a stratified medicine approach for personalised neoadjuvant chemotherapy (NCT)
Retrospective
Retrospective cohort study: a cohort of patients who advanced directly to surgery ("Control group") and a cohort treated with NCT.
Other: Observational Translational Study
Cohort study aimed at developing a stratified medicine approach for personalised neoadjuvant chemotherapy (NCT)

What is the study measuring?

Primary Outcome Measures

Outcome 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
Time Frame: Through study completion, average 4 years
Through study completion, average 4 years
Develop an understanding of radiomic profiles for patients treated with NCT.
Time Frame: Through study completion, average 4 years
Through study completion, average 4 years
Develop an electronic STS Tissue Atlas for 5 high risk subtypes.
Time Frame: Through study completion, average 4 years
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
Time Frame: Through study completion, average 4 years
Through study completion, average 4 years
Develop a nomogram app to predict benefit of NCT and predict risk of recurrence.
Time Frame: Through study completion, average 4 years
Through study completion, average 4 years

Secondary Outcome Measures

Outcome 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
Time Frame: Through study completion, average 4 years
Through study completion, average 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Marsden NHS Foundation Trust

Collaborators

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Cancer Research UK
University of Edinburgh
Andalusian Network for Design and Translation of Advanced Therapies
Institute of Cancer Research, United Kingdom
University of Birmingham
NHS Greater Glasgow and Clyde
Hospitales Universitarios Virgen del Rocío
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Associazione Italiana per la Ricerca sul Cancro
University Hospital Birmingham
The Clatterbridge Cancer Centre NHS Foundation Trust
Instituto de Biomedicina de Sevilla
Freeman Hospital, UK
Liverpool Hospital
the Fundación Científica de la Asociación Española Contra el Cáncer

Investigators

  • Study Director: Robin Jones, MD, Royal Marsden NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 19, 2021

Primary Completion (Estimated)

March 31, 2026

Study Completion (Estimated)

June 30, 2028

Study Registration Dates

First Submitted

May 26, 2022

First Submitted That Met QC Criteria

February 18, 2026

First Posted (Actual)

February 25, 2026

Study Record Updates

Last Update Posted (Actual)

February 25, 2026

Last Update Submitted That Met QC Criteria

February 18, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCR 5337
  • 2021-001437-39 (EudraCT Number)
  • 286407 (Other Identifier: IRAS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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