Localized High-Risk Soft Tissue Sarcomas Of The Extremities And Trunk Wall In Adults: An Integrating Approach Comprising Standard Vs Histotype-Tailored Neoadjuvant Chemotherapy

Inclusion Criteria

• •1. Soft tissue sarcoma of adults, primary or locally recurrent, with spindle-cell or pleomorphic histology, belonging to one of the following for the randomization (Group1):
• •myxoid-Round Cell liposarcoma (cellular component \>5 %), leiomyosarcoma, synovial sarcoma, malignant peripheral nerve sheat tumor, undifferentiated pleomorphic sarcoma (ex Malignant fibrous histiocytoma)
• •Or belonging to one of the following for the registration (Group 2):
• •myxofibrosarcoma, unclassified Spindle Cell, pleomorphic liposarcoma, pleomorphic rabdomiosarcoma Or belonging to either group but not being evaluable for response (re-excision after previous inadequate resection or primary definitive surgery) (Group3).
• •The histological diagnosis must be made according to the WHO criteria and will have to be centrally reviewed before randomization.
• •2. High malignancy grade: grade 3 of 3, according to Coindre, or grade 2 at biopsy with a radiological evidence of more than 50% of necrosis in the tumor mass.
• •3. Deep seated extremities, girdles and/or superficial trunk (thoracic or abdominal wall)lesion.
• •4. Size of primary tumor (visible or previously inadequately resected) \>5 cm at instrumental staging (CT, MRI), or locally recurrent of any size.
• •5. Age \> 18 years.
• •6. ECOG performance status \<1.
• •7. Adequate bone marrow function:
• •WBC \>3.500/mm3 neutrophil \>1.500/mm3 platelets \>150.000/mm3 hemoglobin \>11 g%.
• •8. Adequate renal (creatinine \<1.3 mg%), and hepatic function (bilirubin \<1.5 mg% and transaminases \<2 x n.v. If ALP \> 2.5 x ULN, ALP LF and/or GGT \< ULN).
• •9. Adequate cardiac function (FE \>50%).
• •10. Signed informed consent.
• •11. Complete compliance of the participating center with the protocol requirements.
• •5. Prior CT and/or RT.
• •6. Serious psychiatric disease that precludes informed consent or limits compliance.
• •7. Medical disease limiting survival to less than two years, limiting compliance or which in the physician's opinion might interfere significantly with the toxicity of the treatments.
• •8. Cardiovascular diseases resulting in a New York Heart Association Functional Status \> 2.
• •9. Uncontrolled bacterial, viral or fungal infection.
• •10. Impossibility of ensuring adequate follow-up.
• •11. Failure to comply with the requirements of the present protocol leading to exclusion of the participating center.