Safety Study of Preoperative Sunitinib and Radiation in Soft Tissue Sarcoma

PHASE1CompletedINTERVENTIONAL
Enrollment

9

Participants

Timeline

Start Date

February 29, 2012

Primary Completion Date

November 30, 2014

Study Completion Date

February 28, 2015

Conditions
Soft Tissue Sarcoma
Interventions
DRUG

Sunitinib

"Patients will receive Sunitinib daily for 2 weeks prior to and then concurrently with irradiation as neoadjuvant treatment. Radiotherapy will be given as intensity modulated radiation therapy with a total dose of 50.4Gy in 28 fractions to each patient (5 1/2 weeks).~Sunitinib will be given in two dose levels. The first dose level will be 25mg Sunitinib per os daily. The second dose level will be 37.5mg sunitinib per os daily. A dose modification schedule according to a 3+3 design will be applied for patient accrual."

Trial Locations (2)

15526

Helios Klinikum Bad Saarow, Bad Saarow

68167

University Medical Center Mannheim, Mannheim

Sponsors
All Listed Sponsors
collaborator

German Research Foundation

OTHER

lead

Heidelberg University

OTHER