Neoadjuvant Adriamycin and Ifosfamide Plus High-Dose ICE in Patients With Soft Tissue Sarcoma (STS)

Phase 2

Completed

• Conditions: Sarcoma, Soft Tissue

• Registration Number: NCT00204646
• Lead Sponsor: University Hospital Tuebingen

Brief Summary

Complete resection is still the only curative treatment option in patients with soft tissue sarcoma (STS). Patients with a non-resectable STS have a dismal prognosis even without evidence of metastatic disease. The aim of this trial is to determine whether neoadjuvant dose-intensive chemo-radiotherapy is a feasible and effective approach in patients with non-resectable STS.

Detailed Description

Not available

Study Timeline

• Study Start: 1999-02
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-20
• Study Completion: 2006-12
• Status Verified: 2007-04
• Last Update Submitted: 2007-04-19
• Last Update Posted: 2007-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (1)

Medical Center II, University of Tuebingen; 🇩🇪 Tuebingen, Germany