Phase II Decentralized Pragmatic Trial of Adjuvant Doxorubicin - Trabectedin Chemotherapy in uLMS

Inclusion Criteria

• •Patients must have histologically confirmed uterine leiomyosarcoma
• •Patients must have localized tumors, AJCC stages 1b to 3 according to the AJCC uterine sarcoma staging system (high risk of relapse population)
• •Patients must have had complete surgical resection of tumor within 3 months prior to initiation of adjuvant chemotherapy, complete surgical resection includes at least a total hysterectomy
• •Patients must have no evidence of residual disease, as proven by CT Chest-Abdomen-Pelvic within 28 days before randomization (exclude potential metastatic patients)
• •Patients must have no history of pelvic radiation (hematologic tolerance of chemotherapy is impaired by pelvic radiation)
• •No prior chemotherapy for the treatment of the uterine leiomyosarcoma
• •Age ≥18 years. Because no dosing or adverse event data are currently available on the use of doxorubicin in combination with trabectedin in patients \<18 years of age, children are excluded from this study.
• •ECOG performance status ≤2 (Karnofsky ≥60%,).
• •Patients must have adequate organ and marrow function as defined below:
• •absolute neutrophil count ≥1,000/mcL
• •platelets ≥100,000/mcL
• •total bilirubin ≤ institutional upper limit of normal (ULN) (except patients with Gilbert's syndrome, who must have total bilirubin \< 3.0 mg/dL)
• •AST(SGOT)/ALT(SGPT) ≤2× institutional ULN
• •eGFR (using 2021 CKD-EPI) ≥40mL/min/1.73m2
• •Albumin \> 28 g/L
• •CPK ≤2× institutional ULN
• •No cardiac dysfunction as proven by LVEF\>50%
• •For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
• •Patients with a prior or concurrent malignancy whose natural history or treatment does not interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
• •Ability to understand and the willingness to sign a written informed consent document.