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

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Tuebingen
• Treatments: Carboplatin; Doxorubicin; Etoposide; Ifosfamide; Isophosphamide mustard; Liposomal doxorubicin

Criteria

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