Trial Information

A Multicenter Phase II Clinical Trial of Neoadjuvant Trabectedin (Yondelis) in Patients With Localized Myxoid / Round Cell Liposarcoma

Trabectedin will be administered 1.5 mg/m2 intravenously over 24 hours every three weeks.
Patients will be assessed weekly by physical exam and / or laboratory testing. Radiological
examination will occur every 6 weeks to evaluate the patient's disease. Patients
participating in this study will undergo a surgery after the completion of the treatment in
order to remove all the detectable disease and to find out if a pathologic complete response
has occurred. Pathological complete response means that with surgery or biopsy no cancer is
found. In this study, patients whose disease has not progressed at the end of the
neoadjuvant treatment will be followed every 6 weeks until progression, 6 months post
definitive surgery or until resolution of any drug-related adverse events (AEs) and
sequelae. Trabectedin will be given at 1.5 mg/m2 over a 24-hour intravenous infusion every 3
weeks for a minimum of 3 and a maximum of 6 cycles of neoadjuvant trabectedin in the absence
of overt disease progression, unmanageable toxicity, patient refusal or treatment delay
longer than 3 weeks for toxicity (except in case of obvious patient benefit).Dexamethasone,
20mg, iv, will be administered within 30 minutes before start of each trabectedin iv
infusion.