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

M.D. Anderson Cancer Center

Status and phase

Not yet enrolling

Phase 2

Conditions

Uterine Leiomyosarcoma

Treatments

Drug: Doxorubicin Hydrochloride

Drug: Trabectedin

Study type

Interventional

Funder types

Other

Identifiers

NCT07076186

2025-0352

NCI-2025-05088 (Other Identifier)

Details and patient eligibility

About

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.

Full description

Primary Objective:

To evaluate disease-free survival (DFS) in patients with FIGO stage 1b and 2 uterine leiomyosarcoma receiving adjuvant chemotherapy by standard-of-care doxorubicin and trabectedin for 6 cycles

Secondary Objectives:

To assess overall survival (OS) in patients with FIGO stage 1b and 2 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 FIGO stage 1b and 2 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 FIGO stage 1b and 2 uterine leiomyosarcoma receiving adjuvant chemotherapy by standard-of-care doxorubicin and trabectedin for 6 cycles
To analyze ctDNA dynamics as a predictor of treatment response and recurrence risk, in patients with FIGO stage 1b and 2 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

Enrollment

48 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 > 2.8mg/dL
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.