Preoperative Radiotherapy for Sarcomas of the Extremities With Intensity-Modulation, Image-Guidance and Small Safety-margins (PREMISS)

Inclusion Criteria:

Histologic and radiographic proof of localized high-risk soft tissue sarcoma meeting the following criteria:

• Lesion originates in extremity

  • upper extremity lesions may occur from the medial border of the scapula to tumors as far distal as the finger tips
  • lower extremity regions include hip girdle tumors commencing at the iliac crest, excluding lesions arising from within the pelvis, and extends to include lesions as far distal as the toes
• AJCC Stage II or III disease (except T1a-tumors or N1)
• Primary presentation or local recurrence
• after biopsy or inadequate surgery resulting in residual tumor in cross-sectional imaging
• Tumors must be considered resectable according to cross sectional imaging, or potentially resectable after preoperative radiotherapy
• ECOG Performance Status 0-2
• Informed Consent

Exclusion Criteria:

• Diagnosis of the following:

  • Primitive neuroectodermal tumor
  • Soft tissue Ewing's sarcoma
  • Extraskeletal osteo- or chondrosarcoma
  • Aggressive fibromatosis (desmoid tumors)
  • Dermatofibrosarcoma protuberans
• Regional nodal disease or unequivocal distant metastasis
• Life expectancy < 1 year
• Pregnancy
• Major medical illness that would preclude study treatment
• History of major wound complication or recurrent skin infection
• Known HIV positivity
• < 2 weeks elapsed from prior surgery or cytotoxic chemotherapy
• persisting acute toxicities > grade 1 in tumor-bearing limb resulting from prior treatment with anti-cancer modalities
• Cytotoxic chemotherapy, targeted therapy or investigational agents concurrent to study treatment
• Prior radiotherapy to the site of present STS.
• Chronic requirement for treatment with immuno¬suppressive agents or steroids.