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

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age18 Years to no maximum
• SexFemale
• Healthy volunteersNo

You may be able to join if

• 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 30 days.
• 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 history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
• 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.

You cannot join if

• Patients who are receiving any other investigational agents.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to doxorubicin or trabectedin or other agents used in study.
• Patients with uncontrolled intercurrent illness per clinical judgment of the study PI and/or treating physician
• Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
• Patients with psychiatric illness/social situations that would limit compliance with study requirements.

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

ABVD regimen. A regimen consisting of doxorubicin, bleomycin, vinblastine and dacarbazine that can be used in the treatment of Hodgkin lymphoma (HL). NCI Drug Dictionary

trabectedin. A tetrahydroisoquinoline alkaloid isolated from the marine tunicate Ecteinascidia turbinate with potential antineoplastic activity. Binding to the minor groove of DNA, trabectedin inteferes with the transcription-coupled nucleotide excision repair machinery to induce lethal DNA strand breaks.and blocks the cell cycle in the G2 phase. NCI Drug Dictionary

Treatments listed in the registry

• Trabectedin (Drug): Given by IV Infusion
• Doxorubicin Hydrochloride (Drug): Given by IV Infusion

Na · Single Group · masking: None

As the registry describes them. Requirements to join, such as a tissue sample, are in the eligibility list above even when on-study procedures are optional. Ask the study team which steps apply to you.

• questionnaires: Part of the study plan

Main goals

• Safety and Adverse Events (AEs) (Through study completion; an average of 1 year)

Planned enrollment: 48 (estimated).

• The University of Texas M. D. Anderson Cancer Center, Houston, Texas

Site status as of Oct 30, 2026. Check the live record before contacting a site.

• ClinicalTrials.gov NCT07076186
• NCI Drug Dictionary: C1326
• NCI Drug Dictionary: C1691

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Oct 12, 2026. Public record; not medical advice.