Actively Recruiting
Phase II Decentralized Pragmatic Trial of Adjuvant Doxorubicin - Trabectedin Chemotherapy in uLMS
Led by M.D. Anderson Cancer Center · Updated on 2026-03-10
48
Participants Needed
1
Research Sites
217 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Phase II Decentralized Pragmatic Trial of Adjuvant Doxorubicin - Trabectedin Chemotherapy in uLMS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed uterine leiomyosarcoma
- Localized tumors at AJCC stages 1b to 3
- Complete surgical tumor removal including at least a total hysterectomy within 3 months before chemotherapy
- No evidence of residual disease by CT chest-abdomen-pelvic within 28 days before randomization
- No history of pelvic radiation
- No prior chemotherapy for uterine leiomyosarcoma
- Age 18 years or older
- ECOG performance status 0 to 2 (Karnofsky 60% or higher)
- Adequate organ and marrow function as defined by specified blood counts and lab values
- No cardiac dysfunction with left ventricular ejection fraction above 50%
- Controlled hepatitis B or cured hepatitis C infection as specified
- Prior or concurrent malignancies allowed if they do not interfere with study safety or efficacy
- Ability to understand and willingness to sign informed consent
You will not qualify if you...
- Receiving any other investigational agents
- Allergic reactions to doxorubicin, trabectedin, or related compounds
- Uncontrolled illnesses as judged by the study doctor
- Psychiatric or social conditions limiting study compliance
- HIV infection with detectable viral load (patients with undetectable viral load on therapy are eligible)
AI-Screening
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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
CONTACT
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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