Phase II Study of Preoperative Radiotherapy for Sarcomas of the Extremities With Intensity-Modulation, Image-Guidance, Small Safety-margins and Brachytherapy Conditioned by Resection Margin
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.