SarcomaPANTHR-SNCT07432932
Precision Medicine Approaches for Neoadjuvant Therapy in High-risk Sarcoma Patients
An observational study of Sarcoma and Sarcoma, Leiomyo-, Adult, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma, Sarcoma, Leiomyo-, Adult, Sarcoma, Synovial, Adult
- What is being tested?
- Observational Translational Study
- How many people
- 800 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Nov 2021to 30 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with one of DDLPS, LMS, SS, vascular sarcomas or MPNST either advancing directly to surgery or receiving neoadjuvant chemotherapy and surgery
Who may be able to join
- 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
Show all 15Show fewer
- 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
Who cannot join
- -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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
The Royal Marsden Hospital
London, SW3 6JJ
Stephanie Elston, 02073528171, PANTHRS.Trial@rmh.nhs.uk
About this study
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.
Read the 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.
- Conditions
- Sarcoma, Sarcoma, Leiomyo-, Adult, Sarcoma, Synovial, Adult, Soft Tissue Sarcoma (STS), Soft Tissue Sarcoma Adult, Soft Tissue Sarcoma of the Trunk and Extremities
- Being tested
- Observational Translational Study
- Keywords
- PANTHRS, PANTHRS-S, Sarcoma Accelerator
- Medical subject headings
- Sarcoma, Liposarcoma, Leiomyosarcoma, Hemangiosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational Translational StudyOther
Cohort study aimed at developing a stratified medicine approach for personalised neoadjuvant chemotherapy (NCT)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Observational Translational Study | |
| Retrospective | Retrospective cohort study: a cohort of patients who advanced directly to surgery ("Control group") and a cohort treated with NCT. Receives: Other: Observational Translational Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify a difference in expression profiles, using proteomics, genomics, epigenomics, in tissue samples obtained pre- and post-NCT and post-surgery alone
Measured: Through study completion, average 4 years
Develop an understanding of radiomic profiles for patients treated with NCT.
Measured: Through study completion, average 4 years
Develop an electronic STS Tissue Atlas for 5 high risk subtypes.
Measured: 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
Measured: Through study completion, average 4 years
Develop a nomogram app to predict benefit of NCT and predict risk of recurrence.
Measured: Through study completion, average 4 years
Secondary outcomes (1)
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
Measured: Through study completion, average 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start19 Nov 2021
- Primary completion31 Mar 2026 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Cancer Research, United Kingdom, University of Edinburgh, NHS Greater Glasgow and Clyde, University of Birmingham, University Hospital Birmingham, Cancer Research UK, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz, Hospitales Universitarios Virgen del Rocío, Andalusian Network for Design and Translation of Advanced Therapies, Instituto de Biomedicina de Sevilla, the Fundación Científica de la Asociación Española Contra el Cáncer, Associazione Italiana per la Ricerca sul Cancro, Freeman Hospital, UK, Liverpool Hospital, The Clatterbridge Cancer Centre NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Robin Jones, MD, Study director, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07432932
- Sponsor's protocol ID
- CCR 5337
- Other IDs
- 2021-001437-39, 286407
- Acronym
- PANTHR-S
- Status last verified
- Feb 2026
- First submitted
- 26 May 2022
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Medicine Approaches for Neoadjuvant Therapy in High-risk Sarcoma Patients
- ClinicalTrials.gov ID
- NCT07432932
- Acronym / sponsor ID
- PANTHR-S / CCR 5337
- Conditions
- Sarcoma, Sarcoma, Leiomyo-, Adult, Sarcoma, Synovial, Adult, Soft Tissue Sarcoma (STS), Soft Tissue Sarcoma Adult, Soft Tissue Sarcoma of the Trunk and Extremities
- Keywords
- PANTHRS, PANTHRS-S, Sarcoma Accelerator
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Institute of Cancer Research, United Kingdom, University of Edinburgh, NHS Greater Glasgow and Clyde, University of Birmingham, University Hospital Birmingham, Cancer Research UK, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz, Hospitales Universitarios Virgen del Rocío, Andalusian Network for Design and Translation of Advanced Therapies, Instituto de Biomedicina de Sevilla, the Fundación Científica de la Asociación Española Contra el Cáncer, Associazione Italiana per la Ricerca sul Cancro, Freeman Hospital, UK, Liverpool Hospital, The Clatterbridge Cancer Centre NHS Foundation Trust
- Study start
- 19 Nov 2021 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 25 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective | – | Other: Observational Translational StudyProspective 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 | – | Other: Observational Translational StudyRetrospective cohort study: a cohort of patients who advanced directly to surgery ("Control group") and a cohort treated with NCT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with one of DDLPS, LMS, SS, vascular sarcomas or MPNST either advancing directly to surgery or receiving neoadjuvant chemotherapy and surgery
Key inclusion criteria (15 listed)
- Written informed consent for the prospective cohort
- 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
Key exclusion criteria (4 listed)
- -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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational Translational StudyCohort study aimed at developing a stratified medicine approach for personalised neoadjuvant chemotherapy (NCT) | Other | Prospective, Retrospective |
Primary outcome
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
Develop an understanding of radiomic profiles for patients treated with NCT.
Time frame: 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
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
Develop a nomogram app to predict benefit of NCT and predict risk of recurrence.
Time frame: Through study completion, average 4 years
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Sarcoma
Active, not recruitingObservational study
Genomic Structural Variation in Cancer Susceptibility
Breast Cancer, Colon Cancer
Active, not recruitingPhase 2
Spearhead 1 Study in Subjects With Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma
Synovial Sarcoma, Myxoid Liposarcoma
RecruitingPhase 2
Testing Atezolizumab With Selinexor in People ≥ 12 Years Old With Alveolar Soft Part Sarcoma, AXIOM Trial
Advanced Alveolar Soft Part Sarcoma, Advanced Soft Tissue Sarcoma
RecruitingPhase 1/2
Study of Lurbinectedin Monotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Ewing Sarcoma
Refractory Ewing Sarcoma, Relapsed Ewing Sarcoma
RecruitingPhase 1
Anti-GD2 ADC M3554 in Advanced Solid Tumors
Advanced Solid Tumor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robin Jones, MD study director
Royal Marsden NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcoma and Sarcoma, Leiomyo-, Adult, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephanie Elston, MSc (02073528171, PANTHRS.Trial@rmh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026; AzTrials last refreshed its copy on 6 Nov 2026.