This trial compares trabectedin alone to trabectedin in combination with regional hyperthermia in patients with high-risk soft tissue sarcoma. The study is designed to demonstrate a significant benefit for sarcoma-therapy by adding regional hyperthermia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
The rationale for combining Tr and RHT is based on immune mechanisms induced by local heating of which are independent of the anti-tumor effects of Tr. Recent results demonstrate that an acute inflammation at the site of the heated tumor area and "danger signals" are responsible for immune reactions against tumor and metastases (Frey 2012). Abscopal effects after local radiation of tumors with response of distant metastases are induced by similar mechanisms like heat stress (Formenti 2013, Golden 2015). The long-term results for soft-tissue sarcoma are consistent with abscopal effects induced by RHT in a randomized trial compared to chemotherapy alone (Issels 2018).
Ludwig-Maximilians University of Munich, Klinikum Großhadern
Munich, Bavaria, Germany
Helios Klinikum Bad Saarow
Bad Saarow, Germany
Charité - Universitätsmedizin Berlin
Berlin, Germany
Helios Klinikum Berlin-Buch
Berlin, Germany
Progression-free Survival (PFS)
Time frame: planned after 46 events after start of recruitment which are expected to occur after 27 month
Radiological response according to RECIST
Time frame: planned after 46 events after start of recruitment which are expected to occur after 27 month
Overall Survival (OS)
Time frame: planned after 46 events after start of recruitment which are expected to occur after 27 month
Treatment related toxicity (hematological, renal, hepatic, others)
Time frame: planned after 46 events after start of recruitment which are expected to occur after 27 month
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Universitätsklinikum Erlangen
Erlangen, Germany