A Phase II Study Evaluating Neo-/Adjuvant EIA Chemotherapy, Surgical Resection and Radiotherapy in High-risk Soft Tissue Sarcoma
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Disease-free survival will be calculated from the time of definite surgery to radiologically proven local or distant failure or patient´s death due to sarcoma related cause.
2 years after study completion
Gerlinde Egerer, MD
Department of Hematology, Heidelberg University Clinics
Germany: Federal Institute for Drugs and Medical Devices