Skip to main content
Back to Trials
NCT07076186PHASE2Recruiting

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

M.D. Anderson Cancer Center

Start Date

10/2/2025

Completion Date

12/2/2029

Summary

To find out if receiving standard chemotherapy (doxorubicin and trabectedin) can extend the cancer-free survival of patients with Stage 1b/2 uterine leiomyosarcoma who had surgery that fully removed the tumor.

Detailed Description

Primary Objective: To evaluate disease-free survival (DFS) in patients with AJCC stage 1b, 2 and 3 uterine leiomyosarcoma receivingadjuvant chemotherapy by standard-of-care doxorubicin and trabectedin for 6 cycles Secondary Objectives: * To assess overall survival (OS) in patients with AJCC stage 1b, 2 and 3 uterine leiomyosarcoma receiving adjuvant chemotherapy by standard-of-care doxorubicin and trabectedin for 6 cycles * To characterize treatment-related toxicity according to Common Terminology Criteria for Adverse Events (CTCAE), in patients with AJCC stage 1b, 2 and 3 uterine leiomyosarcoma receiving adjuvant chemotherapy by standard-of-care doxorubicin and trabectedin for 6 cycles * To evaluate quality of life (QoL) outcomes using patient-reported measures in patients with AJCC stage 1b, 2 and 3 uterine leiomyosarcoma receiving adjuvant chemotherapy by standard-of-care doxorubicin and trabectedin for 6 cycles Exploratory Objectives * To analyze ctDNA dynamics as a predictor of treatment response and recurrence risk, in patients with AJCC stage 1b, 2 and 3 uterine leiomyosarcoma receiving adjuvant chemotherapy by standard-of-care doxorubicin and trabectedin for 6 cycles * To estimate the incidence of germline genetic alterations in patients with localized uLMS * To assess the feasibility of delivering protocol-specified adjuvant chemotherapy (doxorubicin-trabectedin) using a decentralized clinical trial model. * To assess patient satisfaction and acceptability of decentralized trial participation based on Study Participant Feedback Questionnaire (SPFQ). * To compare protocol adherence, data completeness, and safety monitoring fidelity between centralized and decentralized participants. * To explore the impact of decentralization on patient access, representativeness, and trial retention.

Eligibility Criteria

Age Range: 18 years to No maximum

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 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. Exclusion Criteria: * 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.

Interventions

DRUG

Trabectedin

DRUG

Doxorubicin Hydrochloride

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Uterine Leiomyosarcoma

Locations

The University of Texas M. D. Anderson Cancer Center

Houston, Texas 77030

United States