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

Phase 2CompletedNCT00204646

University Hospital Tuebingen

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Sarcoma, Soft Tissue

Interventions

AdriamycinDRUG

IfosfamideDRUG

EtoposideDRUG

CarboplatinDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Medical Center II, University of Tuebingen

Tübingen, Germany

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.