Phase II Study of Neoadjuvant Dose-Intensive Chemotherapy With Adriamycin and Ifosfamide Followed by High-Dose ICE in Locally Advanced Soft Tissue Sarcomas
Phase 2
18 Years
65 Years
18 Years
65 Years
Not Enrolling
Both
Sarcoma, Soft Tissue
Both
Sarcoma, Soft Tissue
Trial Information
Phase II Study of Neoadjuvant Dose-Intensive Chemotherapy With Adriamycin and Ifosfamide Followed by High-Dose ICE in Locally Advanced Soft Tissue Sarcomas
Inclusion Criteria:
- Histologically confirmed STS with locally advanced non-resectable disease
- Metastatic disease is allowed in case of solitary resectable metastases
- Grading according to Coindre > II°
- Measurable tumor lesions
- Age > 18 through 65 years
- Karnofsky status > 70 %
- Written informed consent
Exclusion Criteria:
- Prior chemotherapy
- Intercurrent disease interfering with the adequate administration of study medication
including severe psychological disease
- Insufficient liver-, renal or bone marrow function
- Evidence of pregnancy
- Treatment within another clinical trial
- Uncontrolled viral Infections (HIV,HBV, HCV)
- other malignancies
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Joerg T. Hartmann, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
South West German Cancer Center, Medical Center II, University of Tuebingen
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
jth_005
NCT ID:
NCT00204646
Start Date:
February 1999
Completion Date:
December 2006
Related Keywords:
- Sarcoma, Soft Tissue
- Sarcoma
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