Neoadjuvant and Adjuvant Chemotherapy in High-risk Soft Tissue Sarcoma

A Phase II Study Evaluating Neo-/Adjuvant EIA Chemotherapy, Surgical Resection and Radiotherapy in High-risk Soft Tissue Sarcoma

Neo- and adjuvant chemotherapy is used in high-risk soft tissue sarcoma to improve systemic control. Patients in this trial are treated with 4 cycles of chemotherapy (EIA, etoposide, ifosfamide, adriamycin) preoperatively, followed by local surgery and radiotherapy. An additional 4 cycles of adjuvant chemotherapy is administered. Treatment response is assessed by MRI and CT scans and FDG-PET in a subgroup of patients.

The role of chemotherapy in high-risk soft tissue sarcoma is controversial. Though many patients undergo initial curative resection, distant metastasis is a frequent event resulting in 5-year overall survival rates of only 50 - 60%. Neo-adjuvant and adjuvant chemotherapy has been applied to achieve pre-operative cytoreduction, assess chemosensitivity and to eliminate occult metastasis. The current protocol comprises for cycles of neoadjuvant chemotherapy ((EIA, etoposide 125 mg/m2 iv days 1 and 4, ifosfamide 1500 mg/m2 iv days 1 - 4, doxorubicin 50 mg/m2 day 1, pegfilgrastim 6 mg sc day 5), local surgery and radiotherapy as well as further 4 cycles of adjuvant EIA. Treatment response is assessed by MRI and CT scans and FDG-PET in a subgroup of patients.

Inclusion Criteria:

• Soft tissue sarcoma histology
• Tumor size >= 5 cm
• Deep/extracompartimental localization
• Grade 2/3 (FNCLCC)
• Patients with inadequate previous therapy
• Age 18-65 years
• normal bone marrow function
• normal liver function
• normal renal function
• Karnofsky index >=80%

Exclusion Criteria:

• Chordoma
• Chondrosarcoma
• Kaposi´ sarcoma
• Neuroblastoma
• Mesothelioma
• Osteosarcoma/Ewings´sarcoma