Soft Tissue Sarcoma
Conditions
Keywords
Soft tissue sarcoma, High-risk, Neoadjuvant, Adjuvant, Chemotherapy, Radiotherapy
Brief summary
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.
Detailed description
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.
Interventions
DRUGEIA chemotherapy
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
Sponsors
German Cancer Research Center
Heidelberg University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free survival | 2 years after study completion | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Grade of histological necrosis | After definite surgery, approx. 12-15 weeks after study inclusion | Grade of histological necrosis in tumor specimen will be assessed after surgery and graded according to Salzer-Kuntschik. |
| Hematological toxicity | Once weekly for an average of 8 months | Hematological toxicity will be assessed by complete blood counts. Toxicity will be graded according to CTCAE. |
| Renal Toxicity | Once weekly for an average of 8 months | Renal toxicity will be assessed by changes from baseline creatinin levels. Toxicity will be graded according to CTCAE. |
| Overall Survival | 2 years after study completion | Overall survival will be calculated as the time interval from the date of therapy induction to patient's death or last follow up. |
| Correlation of Tumor Necrosis and Decline in PET SUV | After tumor resection, approx. 12-15 weeks after study inclusion | Decline in PET SUV will be correlated with grade of histological necrosis in tumor specimen after surgery. |
| Cardiac Toxicity | Every 6 weeks for an average of 8 months | Changes in cardiac ejection fraction will be assessed by echocardiograms. Toxicities will be graded according to CTCAE. |
| Radiologic Tumor Response | Every 6 weeks for an average of 8 months, then every 3 months for 2 years | Tumor response to therapy will be assessed by MRI and CT scans. Response will graded according to RECIST criteria. |
| Liver Toxicity | Once weekly for an average of 8 months | Liver toxicity will be assessed by changes from baseline liver function tests, e.g. ASAT/ALAT. Toxicity will be graded according to CTCAE. |
Countries
Germany
Outcome results
None listed