The purpose of this study is to examine if a short-term treatment with pazopanib, an oral drug inhibiting the growth of blood vessel, can reduce the metabolism of soft-tissue sarcomas and thus facilitate their resection when given prior to surgery. Moreover, the study assesses the prognostic and predictive value of several new biomarkers (endothelial progenitor cells, soluble vascular epithelial growth factor),
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Treatment with pazopanib 800 mg qd for 21 days followed by resection of the tumor after a 7-14 days break
Klinikum Frankfurt-Höchst
Frankfurt am Main, Germany
German Cancer Research Center, Medical PET Group - Biological Imaging
Heidelberg, Germany
University Hospital Heidelberg / National Centre for Tumor Diseases
Heidelberg, Germany
University Hospital Mannheim, Dpt. of Surgery
Mannheim, Germany
Metabolic response rate
Metabolic response rate is defined as the proportion of patients achieving a metabolic response, i.e. a 50% reduction of the mean standardized uptake value (SUVmean) in the post-treatment compared to the pre-treatment FDG-PET-CT
Time frame: day 22-28 (time of post-treatment PET-CT)
Percentage of tumor tissue with regressive alterations upon resection ("Histopathological Response")
Time frame: day 28-35
Decrease in tumor size in MRI according to RECIST 1.1 criteria
Time frame: baseline and day 22-28
Change of FDG influx as well as of transport rates k1-k4 and distribution volume VB and fractal dimension in dynamic PET-CT ("Dynamic PET-CT Response")
Absolute values of all parameters of FDG kinetics will be used for discriminant analysis evaluation.
Time frame: baseline and day 22-28
Number of days for which planned resection is delayed after treatment
Time frame: day 28-35
Number of patients in which adverse events occur during treatment
Adverse events are graded according to NCI Common Terminology Criteria for Adverse Events v4.0 (NCI CTCAE v4)
Time frame: day 1-21
Disease-free survival
Time frame: 3 years
Local recurrence-free survival
Time frame: 3 years
Distant recurrence-free survival
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Time frame: 3 years
Overall survival
Time frame: 3 years
Decrease in vascularisation in MRI according to adapted Choi Criteria
Adapted Choi Criteria as defined ín Stacchiotti S, Collini P, Messina A, Morosi C, Barisella M, Bertulli R, et al. High-grade soft-tissue sarcomas: tumor response assessment--pilot study to assess the correlation between radiologic and pathologic response by using RECIST and Choi criteria. Radiology 2009;251(2):447-56.
Time frame: baseline and day 22-28
Decrease in MRI apparent diffusion coefficient (ADC) values
ADC values as defined by Dudeck O, Zeile M, Pink D, Pech M, Tunn PU, Reichardt P, et al. Diffusion-weighted magnetic resonance imaging allows monitoring of anticancer treatment effects in patients with soft-tissue sarcomas. J Magn Reson Imaging 2008;27(5):1109-13.
Time frame: baseline and day 22-28