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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
ifosfamide 1500 mg/m² iv days 1 - 4, etoposide 125 mg/m² iv days 1 and 4, and adriamycin 50 mg/m² iv day 1
Heidelberg University Clinics
Heidelberg, Baden-Wurttemberg, Germany
Disease-free survival
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.
Time frame: 2 years after study completion
Overall Survival
Overall survival will be calculated as the time interval from the date of therapy induction to patient's death or last follow up.
Time frame: 2 years after study completion
Grade of histological necrosis
Grade of histological necrosis in tumor specimen will be assessed after surgery and graded according to Salzer-Kuntschik.
Time frame: After definite surgery, approx. 12-15 weeks after study inclusion
Hematological toxicity
Hematological toxicity will be assessed by complete blood counts. Toxicity will be graded according to CTCAE.
Time frame: Once weekly for an average of 8 months
Renal Toxicity
Renal toxicity will be assessed by changes from baseline creatinin levels. Toxicity will be graded according to CTCAE.
Time frame: Once weekly for an average of 8 months
Liver Toxicity
Liver toxicity will be assessed by changes from baseline liver function tests, e.g. ASAT/ALAT. Toxicity will be graded according to CTCAE.
Time frame: Once weekly for an average of 8 months
Correlation of Tumor Necrosis and Decline in PET SUV
Decline in PET SUV will be correlated with grade of histological necrosis in tumor specimen after surgery.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: After tumor resection, approx. 12-15 weeks after study inclusion
Cardiac Toxicity
Changes in cardiac ejection fraction will be assessed by echocardiograms. Toxicities will be graded according to CTCAE.
Time frame: Every 6 weeks for an average of 8 months
Radiologic Tumor Response
Tumor response to therapy will be assessed by MRI and CT scans. Response will graded according to RECIST criteria.
Time frame: Every 6 weeks for an average of 8 months, then every 3 months for 2 years