Precision Medicine Approaches for Neoadjuvant Therapy in High-risk Sarcoma Patients
PANTHR-S
3 other identifiers
observational
800
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2021
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 19, 2021
CompletedFirst Submitted
Initial submission to the registry
May 26, 2022
CompletedFirst Posted
Study publicly available on registry
February 25, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2028
ExpectedFebruary 25, 2026
February 1, 2026
4.4 years
May 26, 2022
February 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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 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
Through study completion, average 4 years
Study Arms (2)
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.
Interventions
Cohort study aimed at developing a stratified medicine approach for personalised neoadjuvant chemotherapy (NCT)
Eligibility Criteria
Patients with one of DDLPS, LMS, SS, vascular sarcomas or MPNST either advancing directly to surgery or receiving neoadjuvant chemotherapy and surgery
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milanocollaborator
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díazcollaborator
- Hospitales Universitarios Virgen del Rocíocollaborator
- Andalusian Network for Design and Translation of Advanced Therapiescollaborator
- Instituto de Biomedicina de Sevillacollaborator
- the Fundación Científica de la Asociación Española Contra el Cáncercollaborator
- Associazione Italiana per la Ricerca sul Cancrocollaborator
- Freeman Hospital, UKcollaborator
- Liverpool Hospitalcollaborator
- The Clatterbridge Cancer Centre NHS Foundation Trustcollaborator
- Royal Marsden NHS Foundation Trustlead
- Institute of Cancer Research, United Kingdomcollaborator
- University of Edinburghcollaborator
- NHS Greater Glasgow and Clydecollaborator
- University of Birminghamcollaborator
- University Hospital Birminghamcollaborator
- Cancer Research UKcollaborator
Study Sites (1)
The Royal Marsden Hospital
London, SW3 6JJ, United Kingdom
Biospecimen
Biopsy specimen, surgical specimen, blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Robin Jones, MD
Royal Marsden NHS Foundation Trust
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 26, 2022
First Posted
February 25, 2026
Study Start
November 19, 2021
Primary Completion
March 31, 2026
Study Completion (Estimated)
June 30, 2028
Last Updated
February 25, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share