NCT07432932 Precision Medicine Approaches for Neoadjuvant Therapy in High-risk Sarcoma Patients
| NCT ID | NCT07432932 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Royal Marsden NHS Foundation Trust |
| Condition | Sarcoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 800 participants |
| Start Date | 2021-11-19 |
| Primary Completion | 2026-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 800 participants in total. It began in 2021-11-19 with a primary completion date of 2026-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Robin Jones, MD
STUDY DIRECTOR
Royal Marsden NHS Foundation Trust
Frequently Asked Questions
Who can join the NCT07432932 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Sarcoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07432932 currently recruiting?
Yes, NCT07432932 is actively recruiting participants. Contact the research team at PANTHRS.Trial@rmh.nhs.uk for enrollment information.
Where is the NCT07432932 trial being conducted?
This trial is being conducted at London, United Kingdom.
Who is sponsoring the NCT07432932 clinical trial?
NCT07432932 is sponsored by Royal Marsden NHS Foundation Trust. The principal investigator is Robin Jones, MD at Royal Marsden NHS Foundation Trust. The trial plans to enroll 800 participants.