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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT07076186
Phase
PHASE2
Status
Recruiting
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Conditions

  • Uterine Leiomyosarcoma

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Trabectedin — DRUG
    Given by IV Infusion
  • Doxorubicin Hydrochloride — DRUG
    Given by IV Infusion

Study Details

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.

Key Dates

Start date
Oct 2, 2025
Status verified
Mar 2026
Primary completion
Dec 2, 2027
Completion
Dec 2, 2029

Study Design

Enrollment
48 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Phase II Single Arm Treatment with Doxorubicin and Trabectedin
    Participants will receive treatment on an outpatient and standard of care basis

Primary Outcome Measure

Safety and Adverse Events (AEs) [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas M. D. Anderson Cancer CenterHoustonTexas77030
Elise Nassif Haddad, MD
[email protected]
281-460-0607
Elise Nassif Haddad, MD (PRINCIPAL_INVESTIGATOR)

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By research site
The University of Texas M. D. Anderson Cancer Center· Houston, TX

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