Neoadjuvant Adriamycin and Ifosfamide Plus High-Dose ICE in Patients With Soft Tissue Sarcoma (STS)

Phase II Study of Neoadjuvant Dose-Intensive Chemotherapy With Adriamycin and Ifosfamide Followed by High-Dose ICE in Locally Advanced Soft Tissue Sarcomas

Complete resection is still the only curative treatment option in patients with soft tissue sarcoma (STS). Patients with a non-resectable STS have a dismal prognosis even without evidence of metastatic disease. The aim of this trial is to determine whether neoadjuvant dose-intensive chemo-radiotherapy is a feasible and effective approach in patients with non-resectable STS.

Inclusion Criteria:

• Histologically confirmed STS with locally advanced non-resectable disease
• Metastatic disease is allowed in case of solitary resectable metastases
• Grading according to Coindre > II°
• Measurable tumor lesions
• Age > 18 through 65 years
• Karnofsky status > 70 %
• Written informed consent

Exclusion Criteria:

• Prior chemotherapy
• Intercurrent disease interfering with the adequate administration of study medication including severe psychological disease
• Insufficient liver-, renal or bone marrow function
• Evidence of pregnancy
• Treatment within another clinical trial
• Uncontrolled viral Infections (HIV,HBV, HCV)
• other malignancies