Status: Closed
Activation Date: 1999OCT05
Closing Date: 2003DEC15
Phase: III
Description: Randomized Trial of Adjuvant Chemotherapy with High-dose Doxorubicin, Ifosfamide and Lenograstim (G-CSF) in High Grade Soft Tissue Sarcoma
Eligibility: Patients with histologically proven high grade soft tissue sarcoma (grade II or III) with no evidence of metastases.
Objective: To compare the effect of treatment with ifosfamide and high dose doxorubicin with filgrastim versus observation on overall survival and relapse free survival.
Participation: Not limited
Lay Description: The purpose of the study is to find out whether it is better to receive chemotherapy after standard therapy or standard therapy alone. To do this, half of the patients in the study will get doxorubicin, ifosfamide, G-CSF (filgrastim) with standard therapy, and the other half will receive standard therapy only. Standard therapy is surgery to remove the tumor and in some cases radiation is added as well.
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| Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
| SARCOMA | SR3 | 13 | 0 | 0 | 0 |
(Core size is 0.6 mm)
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Fluid Samples| Disease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
| SARCOMA | SR3 | 13 | 0 | 0 |
| Disease Site | Trial Code | Patients Accrued | Patients - Whole Blood | Patients - Cellular Component of Blood | Patients - DNA extracted from Blood | Patients - RNA extracted from Blood | Patients - Plasma | Patients - Serum | Patients - Urine | Patients - Buccal |
| SARCOMA | SR3 | 13 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |