A Scandinavian Sarcoma Group Protocol for Patients With High-risk Soft Tissue Sarcoma of the Extremities and Trunk Wall

SSG XX is a phase II trial for high-risk soft tissue sarcomas (STS) of the extremities and trunk wall. Prognostic factors (histopathological markers) are used to identify high-risk tumors. SSG XX will evaluate chemo- and radiotherapy given adjuvantly to these patients. In a specified group of patients also preoperatively given therapy will be studied.

Sex

All

Minimum age

18 Years

Maximum age

75 Years

Inclusion Criteria:

Group A: Histological high-grade malignancy soft tissue sarcomas of the extremity and trunk wall.

Patients fulfilling the high-risk criteria defined above (see detailed description) Group B: Patients with histological high-grade malignancy soft tissue sarcomas of the extremity and trunk wall for whom surgery carries an obvious risk of intralesional margin

Other inclusion criteria for therapy group A and group B

* Age ≥ 18 y and ≤ 75 y
* WHO grade 0-1
* Adequate cardiac function (LVEF ≥ 50%)
* Normal GFR (clearance)
* Adequate haematologic and liver function
* All histotypes except those listed below

Exclusion Criteria:

The following histological types:

* Extraskeletal osteosarcoma and - chondrosarcoma, Ewing/PNET, rhabdomyosarcoma, Kaposi´s sarcoma, malignant mesenchymoma, clear cell sarcoma, alveolar soft part sarcoma, epithelioid sarcoma
* Radiation induced sarcoma
* No previous anthracycline treatment
* Less than 5 years free of another primary malignancy
* More than 12 weeks have elapsed since primary surgery (Group A)
* More than 4 weeks from diagnostic biopsy to start of chemotherapy (Group B)

• BACKGROUNDEngellau J, Samuelsson V, Anderson H, Bjerkehagen B, Rissler P, Sundby-Hall K, Rydholm A. Identification of low-risk tumours in histological high-grade soft tissue sarcomas. Eur J Cancer. 2007 Sep;43(13):1927-34. doi: 10.1016/j.ejca.2007.05.018. Epub 2007 Jul 12. PMID 17627813
• BACKGROUNDEngellau J, Bendahl PO, Persson A, Domanski HA, Akerman M, Gustafson P, Alvegard TA, Nilbert M, Rydholm A. Improved prognostication in soft tissue sarcoma: independent information from vascular invasion, necrosis, growth pattern, and immunostaining using whole-tumor sections and tissue microarrays. Hum Pathol. 2005 Sep;36(9):994-1002. doi: 10.1016/j.humpath.2005.07.008. PMID 16153463
• DERIVEDHall KS, Bruland OS, Bjerkehagen B, Lidbrink E, Jebsen N, Hagberg H, Papworth K, Hagberg O, Trovik C, Bauer H, Eriksson M. Preoperative accelerated radiotherapy combined with chemotherapy in a defined cohort of patients with high risk soft tissue sarcoma: a Scandinavian Sarcoma Group study. Clin Sarcoma Res. 2020 Nov 17;10(1):22. doi: 10.1186/s13569-020-00145-5. PMID 33292545
• DERIVEDSundby Hall K, Bruland OS, Bjerkehagen B, Zaikova O, Engellau J, Hagberg O, Hansson L, Hagberg H, Ahlstrom M, Knobel H, Papworth K, Zemmler M, Goplen D, Bauer HCF, Eriksson M. Adjuvant chemotherapy and postoperative radiotherapy in high-risk soft tissue sarcoma patients defined by biological risk factors-A Scandinavian Sarcoma Group study (SSG XX). Eur J Cancer. 2018 Aug;99:78-85. doi: 10.1016/j.ejca.2018.05.011. Epub 2018 Jun 19. PMID 29929092