NCT07076186

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_2

Timeline
44mo left

Started Oct 2025

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress14%
Oct 2025Dec 2029

First Submitted

Initial submission to the registry

July 14, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 22, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

October 2, 2025

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2027

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2029

Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

2.2 years

First QC Date

July 14, 2025

Last Update Submit

March 6, 2026

Conditions

Uterine Leiomyosarcoma

Outcome Measures

Primary Outcomes (1)

  • Safety and Adverse Events (AEs)

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

    Through study completion; an average of 1 year

Study Arms (1)

Phase II Single Arm Treatment with Doxorubicin and Trabectedin

EXPERIMENTAL

Participants will receive treatment on an outpatient and standard of care basis

Drug: TrabectedinDrug: Doxorubicin Hydrochloride

Interventions

TrabectedinDRUG

Given by IV Infusion

Phase II Single Arm Treatment with Doxorubicin and Trabectedin
Doxorubicin HydrochlorideDRUG

Given by IV Infusion

Phase II Single Arm Treatment with Doxorubicin and Trabectedin

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify 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 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
  • +6 more criteria

You may not qualify 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

MeSH Terms

Interventions

TrabectedinDoxorubicin

Intervention Hierarchy (Ancestors)

DioxolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrahydroisoquinolinesIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydrates

Study Officials

  • Elise Nassif Haddad, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elise Nassif Haddad, MD

CONTACT

(281) 460-0607efnassif@mdanderson.org

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2025

First Posted

July 22, 2025

Study Start

October 2, 2025

Primary Completion (Estimated)

December 2, 2027

Study Completion (Estimated)

December 2, 2029

Last Updated

March 10, 2026

Record last verified: 2026-03

Locations

US(1)