Phase I-II Trial, Multicenter, Open, Exploring Trabectedin Plus Radiotherapy in Soft Tissue Sarcoma Patients (TRASTS)
Phase I-II trial that combines trabectedin plus radiotherapy for tumor reduction response measure in two cohorts of patients:
Cohort A: Patients with diagnosis of non-operable or unresectable or not oncologically recommended metastasectomy of limited to lung metastases soft tissue sarcoma.
Cohort B: Patients with locally advanced resectable Myxoid Liposarcoma. Phase I: escalating dose of 1.3 or 1.5 mg/m2. Radiotherapy for cohort A: 30Gy in 10 fractions (3Gy/fraction) Radiotherapy for cohort B: 45Gy in 25 fractions (1.8Gy/fraction) A translational substudy is developed to analyse different biomarkers predictive value.
|Study start date||2014-10-17|