Actively Recruiting
Phase II Decentralized Pragmatic Trial of Adjuvant Doxorubicin and Trabectedin Chemotherapy in Uterine Leiomyosarcoma
Led by M.D. Anderson Cancer Center · Updated on 2026-03-10
48
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether standard chemotherapy with doxorubicin and trabectedin can extend cancer-free survival in patients who have undergone surgery for Stage 1b or 2 uterine leiomyosarcoma. This study focuses on patients who had complete tumor removal and aims to assess disease-free survival as the primary objective, along with overall survival, treatment side effects, quality of life, and genetic markers related to treatment response and recurrence risk. Participants will receive six cycles of adjuvant chemotherapy with doxorubicin and trabectedin given by intravenous infusion on an outpatient basis. This treatment follows surgery and is provided as standard care. The study is a Phase II, single-arm trial without masking or placebo, and it is decentralized, allowing patients to receive care at their usual treatment centers. During the study, participants will be monitored for safety and adverse events for about one year. Researchers will collect blood samples to analyze circulating tumor DNA and assess quality of life through patient-reported measures. The study also includes assessments of organ function and treatment toxicity. Participation involves regular visits for chemotherapy administration and follow-up evaluations to track treatment effects and disease status over time.
CONDITIONS
Brief Title
Phase II Decentralized Pragmatic Trial of Adjuvant Doxorubicin - Trabectedin Chemotherapy in uLMS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have histologically confirmed uterine leiomyosarcoma
- Patients must have localized tumors, AJCC stages 1b to 3
- Complete surgical removal of tumor including at least total hysterectomy within 3 months prior to chemotherapy
- No evidence of residual disease confirmed by CT chest, abdomen, and pelvis within 28 days before randomization
- No prior pelvic radiation
- No prior chemotherapy for uterine leiomyosarcoma
- Age 18 years or older
- ECOG performance status 0 to 2
- Adequate organ and marrow function including neutrophil count ≥1,000/mcL, platelets ≥100,000/mcL, bilirubin within normal limits (except Gilbert's syndrome), AST/ALT ≤2x institutional limit, eGFR ≥40 mL/min/1.73m2, albumin >2.8 mg/dL, CPK ≤2x institutional limit
- No cardiac dysfunction with LVEF >50%
- For hepatitis B or C infections, viral load must be controlled or undetectable
- Patients with prior or concurrent malignancy not interfering with study
- Ability to understand and sign informed consent
You will not qualify if you...
- Receiving any other investigational agents
- History of allergic reactions to doxorubicin, trabectedin, or similar compounds
- Uncontrolled intercurrent illness
- Psychiatric or social conditions limiting study compliance
- HIV infection with detectable viral load within 6 months
- Prior chemotherapy for uterine leiomyosarcoma
- Prior pelvic radiation therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 cycles
Participants receive adjuvant chemotherapy with doxorubicin and trabectedin by IV infusion for 6 cycles on an outpatient basis.
Outpatient visits for each chemotherapy cycle
Duration - Up to 1 year
Participants are monitored for safety, adverse events, and outcomes including disease-free survival and overall survival after completing chemotherapy.
Regular follow-up visits for safety and outcome assessments
Trial Site Locations
Total: 1 location
1
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
E
Elise Nassif Haddad, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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