Table 1

Inclusion and exclutsion criteria

Inclusion criteriaExclusion criteria
  • ▸ Histological proven soft tissue sarcoma except the following entities: angiosarcoma, gastrointestinal stromal tumor (GIST), Ewing-sarcoma, dermatofibrosarcoma protuberans, embryonal rhabdomyosarcoma

  • ▸ The tumour appears to be resectable or resectability is expected after prior treatment

  • ▸ Age of 18 years or older

  • ▸ Eastern cooperative oncology group (ECOG) performance status 0 or 1

  • ▸ Normal organ function (kidney, liver, bone marrow)

  • ▸ Written informed consent

  • ▸ Sufficient contraception (Pearl-Index <1)

  • ▸ Intake of inductors or inhibitors of CYP3A4

  • ▸ Prior therapy with receptor tyrosine kinase inhibitors or conventional chemotherapy until 4 weeks before study inclusion

  • ▸ History of myocardial infarction, cardiac insuffiency (NYHA grade III or IV), apoplex, thrombosis or embolism

  • ▸ Major surgery 4 weeks before study inclusion

  • ▸ Uncontrolled medical disease such as art. hypertension or diabetes mellitus

  • ▸ Antihypertensive medication with more than 2 drugs

  • ▸ Therapeutical anticoagulation with coumadin or similar medication (this does not include ASS and low-dose heparins medication)

  • ▸ Known allergy or intolerance of study medication

  • ▸ Known hereditary coagulopathy

  • ▸ History or other malignancies during the last year before study inclusion

  • ▸ Metastatic disease with the exception of a singular metachronous metastatic lesion

  • ▸ Pregnancy

  • ▸ Known allergy to sunitinib