Status: Closed
Activation Date: 2007JUL03
Closing Date: 2010MAY11
Phase: III
Description: Randomized Trial of Single Agent Doxorubicin Vs. Doxorubicin plus Ifosfamide in First Line Treatment of Advanced or Metastatic Soft Tissue Sarcoma
Eligibility: Patients with advanced or metastatic soft tissue sarcoma (FNLCC grades 2-3) with RECIST measurable lesions and at least 6 months since adjuvant chemotherapy and PS < 1 (WHO).
Objective: Overall survival; Response, toxicity and treatment related mortality.
Participation: Open to member centres
Lay Description: The objective is to determine whether intensive combination chemotherapy with ifosfamide and doxorubicin is superior to doxorubicin alone in terms of overall survival.
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Hide Tissue Samples
| Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
| SARCOMA | SR5 | 13 | 9 | 10 | 10 |
(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 | SR5 | 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 | SR5 | 13 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |