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| ID | Type | Description | Link |
|---|---|---|---|
| 2004-002501-72 | EudraCT Number |
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| Name | Class |
|---|---|
| German Cancer Research Center | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Experimental | All patients receive 4 cycles of EIA chemotherapy pre- and postoperatively. There is no further observation arm. The study is non-randomized. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EIA chemotherapy | Drug | 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 years after study completion |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 years after study completion |
| Grade of histological necrosis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gerlinde Egerer, MD | Department of Hematology, Heidelberg University Clinics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heidelberg University Clinics | Heidelberg | Baden-Wurttemberg | 69120 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24885755 | Derived | Roeder F, Lehner B, Schmitt T, Kasper B, Egerer G, Sedlaczek O, Grullich C, Mechtersheimer G, Wuchter P, Hensley FW, Huber PE, Debus J, Bischof M. Excellent local control with IOERT and postoperative EBRT in high grade extremity sarcoma: results from a subgroup analysis of a prospective trial. BMC Cancer. 2014 May 20;14:350. doi: 10.1186/1471-2407-14-350. | |
| 22152120 |
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| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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Grade of histological necrosis in tumor specimen will be assessed after surgery and graded according to Salzer-Kuntschik.
| 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. | 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. | 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. | 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. | 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. | 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. | Every 6 weeks for an average of 8 months, then every 3 months for 2 years |
| Schmitt T, Lehner B, Kasper B, Bischof M, Roeder F, Dietrich S, Dimitrakopoulou-Strauss A, Strauss LG, Mechtersheimer G, Wuchter P, Ho AD, Egerer G. A phase II study evaluating neo-/adjuvant EIA chemotherapy, surgical resection and radiotherapy in high-risk soft tissue sarcoma. BMC Cancer. 2011 Dec 7;11:510. doi: 10.1186/1471-2407-11-510. |