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

University Hospital Tuebingen

Status and phase: Completed; Phase 2

Conditions: Sarcoma, Soft Tissue

Treatments: Drug: Adriamycin; Drug: Ifosfamide; Drug: Etoposide; Drug: Carboplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT00204646

jth_005

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)