Table 1 Inclusion and exclusion criteria
Criteria | Details |
|---|---|
Inclusion | 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Age ≥ 18 years 4. For women of childbearing potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 52 weeks after the end of RT 5. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner 52 weeks after RT 6. Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration 7. Pathologically (histologically or cytologically) proven diagnosis of high-grade (grade 2 or 3) STS of the deep trunk and/or extremity. Clinical evidence should be documented, and may consist of pathology or imaging, and should be sufficient to estimate the size of the primary (for T stage) 8. Primary site deemed resectable prior to the start of trial 9. AJCC 8th edition staging T1-4 N0 M0 10. Patients must have clinically or radiographically evident measurable disease at the primary site 11. Pre-RT MRI within 4 weeks of the start of RT 12. ECOG Performance Status 0 to 3 13. Deemed a surgical candidate 14. Patient agrees to blood and plasma preservation for future analysis. |
Exclusion | 1. Contraindications to an MRI 2. Positive urine pregnancy test 3. Gross total excision of primary STS, including an unplanned excision 4. Superficial sarcoma located primarily in the subcutaneous or cutaneous tissue 5. Evidence of metastatic disease 6. Prior RT to the region of the study cancer that would result in overlap of RT fields 7. Patients with a medical condition or social situation that, at the discretion of the principal investigator, would preclude them from completion of the trial |