Trabectedin Plus Radiotherapy in Soft Tissue Sarcoma Patients
Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
Summary
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. Cohort C: Patients
with retroperitoneal and resectable soft tissue sarcoma (liposarcoma and leiomyosarcoma)
Phase I: escalating dose of 1.3 or 1.5 mg/m2. Phase I for cohort C: de-escalating dose of 1.5
or 1.3mg/m2 Radiotherapy for cohort A: 30Gy in 10 fractions (3Gy/fraction) Radiotherapy for
cohort B: 45Gy in 25 fractions (1.8Gy/fraction) Radiotherapy for cohort C: 45Gy in 25
fractions (1.8Gy/fraction) A translational substudy is developed to analyse different
biomarkers predictive value.