Health TrialsbyHealthPanel

Precision Medicine Approaches for Neoadjuvant Therapy in High-risk Sarcoma Patients

ConditionsSarcomaSarcoma, Leiomyo-, AdultSarcoma, Synovial, AdultSoft Tissue Sarcoma (STS)Soft Tissue Sarcoma AdultSoft Tissue Sarcoma of the Trunk and ExtremitiesSoft Tissue Sarcoma of the LimbRetroperitoneal SarcomaLiposarcoma, DedifferentiatedLiposarcomaLeiomyosarcoma (LMS)Angiosarcoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRoyal Marsden NHS Foundation Trust

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Greater than 5cm or Grade 3

Deep anatomic location

Disqualifiers

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 population

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

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • Observational Translational Study

    Other intervention

    Cohort study aimed at developing a stratified medicine approach for personalised neoadjuvant chemotherapy (NCT)

Treatment groups

800 Participants
are divided into 2 treatment groups
Group A: Prospective1 intervention
Group B: Retrospective1 intervention

Trial outcomes

Primary outcomes

1

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
2

Develop an understanding of radiomic profiles for patients treated with NCT.

Time frame
Through study completion, average 4 years
3

Develop an electronic STS Tissue Atlas for 5 high risk subtypes.

Time frame
Through study completion, average 4 years
4

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

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

Time frame
Through study completion, average 4 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Royal Marsden NHS Foundation Trust

Lead sponsor

Institute of Cancer Research, United Kingdom

Collaborator

University of Edinburgh

Collaborator

NHS Greater Glasgow and Clyde

Collaborator

University of Birmingham

Collaborator

University Hospital Birmingham

Collaborator

Cancer Research UK

Collaborator

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Collaborator

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Collaborator

Hospitales Universitarios Virgen del Rocío

Collaborator

Andalusian Network for Design and Translation of Advanced Therapies

Collaborator

Instituto de Biomedicina de Sevilla

Collaborator

the Fundación Científica de la Asociación Española Contra el Cáncer

Collaborator

Associazione Italiana per la Ricerca sul Cancro

Collaborator

Freeman Hospital, UK

Collaborator

Liverpool Hospital

Collaborator

The Clatterbridge Cancer Centre NHS Foundation Trust

Collaborator

Source ClinicalTrials.gov
Apply now