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

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

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

Conditions13

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