Actively Recruiting
Precision Medicine Approaches for Neoadjuvant Therapy in High-risk Sarcoma Patients
Led by Royal Marsden NHS Foundation Trust · Updated on 2026-02-25
800
Participants Needed
1
Research Sites
117 weeks
Total Duration
On this page
Sponsors
R
Royal Marsden NHS Foundation Trust
Lead Sponsor
I
Institute of Cancer Research, United Kingdom
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating a personalized approach to neoadjuvant chemotherapy (NCT) for patients with high-risk soft tissue sarcoma (STS), including subtypes such as dedifferentiated liposarcoma, leiomyosarcoma, synovial sarcoma, vascular sarcomas, and malignant peripheral nerve sheath tumor. This study includes both retrospective and prospective collection of tissue samples from patients either undergoing surgery alone or receiving NCT followed by surgery. The goal is to better understand the biology of these cancers and improve treatment strategies through precision medicine. The study takes place across multiple centers in four countries and involves two main patient groups: those who proceed directly to surgery (control group) and those who receive NCT before surgery. Tissue samples and clinical data will be collected before chemotherapy and after surgery to analyze genomic, proteomic, and epigenetic changes. The project also includes retrospective data and tissue collection from similar patient groups to expand the analysis. Data and tissue transfers comply with regulatory and confidentiality standards. Participants will provide consent and undergo tissue sampling, with clinical information pseudonymized for privacy. Researchers will evaluate differences in expression profiles, radiomic data, and develop a tissue atlas, patient-derived models, and a nomogram app to predict treatment benefits and recurrence risks over an average of four years. Outcomes measured include metastases-free survival, recurrence-free survival, and overall survival. The study aims to enhance personalized treatment options for high-risk sarcoma patients.
CONDITIONS
Brief Title
Precision Medicine Approaches for Neoadjuvant Therapy in High-risk Sarcoma Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent for the prospective cohort
- Histopathological diagnosis of high-risk soft tissue sarcoma with subtypes including DDLPS, LMS, SS, vascular sarcomas, or MPNST; other subtypes may be included with principal investigator approval
- Tumor greater than 5 cm or grade 3
- Tumor located in a deep anatomic site
- Disease amenable to biopsy
- Resectable tumor
- Measurable disease by RECIST 1.1
- Age 18 years or older
- WHO performance status 0 to 2
- Medically fit for neoadjuvant chemotherapy (for those receiving it) and surgical resection
- Capable of giving written informed consent and following the study schedule
- Participation in STRASS 2 trial allowed
You will not qualify if you...
- Prior invasive malignancy within the last 5 years, except low-risk malignancies reviewed by the principal investigator
- Known additional malignancy that is progressing or requires active treatment
- Metastatic disease not treatable with curative local therapy
- Any active uncontrolled medical conditions
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Varies by participant depending on treatment group
Participants undergo surgery for tumor resection with immediate post-operative care.
1 surgery visit and several post-operative visits depending on care needs
Duration - Varies depending on chemotherapy schedule
Participants in the neoadjuvant chemotherapy cohort receive chemotherapy before surgery.
Visits scheduled according to chemotherapy treatment plan
Duration - Up to 4 years through study completion
Participants provide tissue samples and clinical data for translational research analyses before and after treatment.
Periodic visits for sample collection and assessments
Duration - Up to 4 years through study completion
Participants are monitored over time for outcomes such as survival and recurrence.
Follow-up visits as scheduled for long-term outcome assessments
Trial Site Locations
Total: 1 location
1
The Royal Marsden Hospital
London, United Kingdom, SW3 6JJ
Actively Recruiting
Research Team
S
Stephanie Elston, MSc
T
Thuy-Giang Nguyen, BSc
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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