Gronchi, AlessandroHindi, NadiaCruz, JosefinaBlay, Jean-YvesLopez-Pousa, AntonioItaliano, AntoineAlvarez, RosaGutierrez, AntonioRincon, InmaculadaSangalli, ClaudiaPerez Aguiar, Jose LuisRomero, JesusMorosi, CarloSunyach, Marie PierreSanfilippo, RobertaRomagosa, CleofeRanchere-Vince, DominiqueDei Tos, Angelo PaoloCasali, Paolo GMartin-Broto, Javier2024-09-102024-09-102019Gronchi A, Hindi N, Cruz J, Blay JY, Lopez-Pousa A, Italiano A, et al. Trabectedin and RAdiotherapy in Soft Tissue Sarcoma (TRASTS): Results of a Phase I Study in Myxoid Liposarcoma from Spanish (GEIS), Italian (ISG), French (FSG) Sarcoma Groups.. EClinicalMedicine. 2019;9:35-43.2589-5370http://hdl.handle.net/20.500.13003/17422https://hdl.handle.net/20.500.12105/22833Background: Myxoid liposarcoma (ML) exhibits a special sensitivity to trabectedin (T) and radiation therapy (RT). Preclinical data suggest a synergistic effect. We aimed to study safety, feasibility and activity of the administration of pre-operative concurrent T and RT in patients affected by localized resectable ML.Methods: Patients received 3?cycles (C) of T in combination with RT (45?Gy) in 25 fractions (1.8?Gy/fraction). Dose Levels for T were: -1 (1.1?mg/m2), 0 (1.3?mg/m2) and 1 (1.5?mg/m2). Primary endpoint was safety; antitumor activity was assessed by RECIST and Choi criteria. This study is registered at ClinicalTrials.gov, number NCT02275286. The phase 1 part of the study is complete and phase 2 is ongoing.Findings: From February 2015 to May 2016, 14 patients (M/F 7/7), median age 36?years (range 24-70) and median tumor size 12.5?cm (range 7-17?cm), were enrolled. One dose limiting toxicity (G3 transaminitis) occurred at Level 0 and one (sepsis due to catheter infection) at Level 1. All patients completed RT. Five patients achieved PR (36%), 8 SD (57%), 1 distant PD (7%) by RECIST, while 12 achieved PR (86%), 1 SD (7%) and 1 distant PD (7%) by Choi criteria. Twelve patients underwent surgery. Median viable residual tumor was 5% (0-60).Interpretation: T in combination with RT showed a favorable safety profile and antitumor activity in localized ML. T dose of 1.5?mg/m2 is the recommended dose for the phase 2 study, which is ongoing.Funding: This study was partially supported by Pharmamar.enghttp://creativecommons.org/licenses/by-nc-nd/4.0/ChemotherapyMyxoid LiposarcomaNeoadjuvantPrognosisRadiotherapySarcomaSurvivalTrabectedinresearch articleAttribution-NonCommercial-NoDerivatives 4.0 International31143880935-4310.1016/j.eclinm.2019.03.007Eclinicalmedicineopen access2-s2.0-85064457164L2001676280