Uterine LeiomyosarcomaPhase 2NCT07076186
Phase II Decentralized Pragmatic Trial of Adjuvant Doxorubicin - Trabectedin Chemotherapy in uLMS
A Phase 2 study testing Trabectedin and Doxorubicin Hydrochloride in people with Uterine Leiomyosarcoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Leiomyosarcoma
- What is being tested?
- Trabectedin and Doxorubicin Hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2025to 2 Dec 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 30 days.
- 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
Show all 21Show fewer
- 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 > 28 g/L
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030
Elise Nassif Haddad, MD, 281-460-0607, efnassif@mdanderson.org
Elise Nassif Haddad, MD
About this study
Official title: Phase II Decentralized Pragmatic Trial of Adjuvant Doxorubicin - Trabectedin Chemotherapy in Uterine Leiomyosarcoma
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.
Read the detailed description
Primary Objective:
To evaluate disease-free survival (DFS) in patients with AJCC stage 1b, 2 and 3 uterine leiomyosarcoma receivingadjuvant chemotherapy by standard-of-care doxorubicin and trabectedin for 6 cycles
Secondary Objectives:
- To assess overall survival (OS) in patients with AJCC stage 1b, 2 and 3 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 AJCC stage 1b, 2 and 3 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 AJCC stage 1b, 2 and 3 uterine leiomyosarcoma receiving adjuvant chemotherapy by standard-of-care doxorubicin and trabectedin for 6 cycles
Exploratory Objectives
- To analyze ctDNA dynamics as a predictor of treatment response and recurrence risk, in patients with AJCC stage 1b, 2 and 3 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
- To assess the feasibility of delivering protocol-specified adjuvant chemotherapy (doxorubicin-trabectedin) using a decentralized clinical trial model.
- To assess patient satisfaction and acceptability of decentralized trial participation based on Study Participant Feedback Questionnaire (SPFQ).
- To compare protocol adherence, data completeness, and safety monitoring fidelity between centralized and decentralized participants.
- To explore the impact of decentralization on patient access, representativeness, and trial retention.
- Conditions
- Uterine Leiomyosarcoma
- Being tested
- Trabectedin, Doxorubicin Hydrochloride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrabectedinDrug
Given by IV Infusion
Given by IV Infusion
| Study group | Role | What they receive |
|---|---|---|
| Phase II Single Arm Treatment with Doxorubicin and Trabectedin | Experimental | Participants will receive treatment on an outpatient and standard of care basis Receives: Drug: Trabectedin; Drug: Doxorubicin Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start2 Oct 2025
- Primary completion2 Dec 2027 (estimated)
- Study completion2 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine LeiomyosarcomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elise Nassif Haddad, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07076186
- Sponsor's protocol ID
- 2025-0352
- Other IDs
- NCI-2025-05088
- Status last verified
- Oct 2026
- First submitted
- 14 Jul 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Decentralized Pragmatic Trial of Adjuvant Doxorubicin - Trabectedin Chemotherapy in Uterine Leiomyosarcoma
- ClinicalTrials.gov ID
- NCT07076186
- Acronym / sponsor ID
- 2025-0352
- Conditions
- Uterine Leiomyosarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 2 Oct 2025 (actual)
- Primary completion
- 2 Dec 2027 (estimated)
- Study completion
- 2 Dec 2029 (estimated)
- First posted
- 22 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Primary Objective:
To evaluate disease-free survival (DFS) in patients with AJCC stage 1b, 2 and 3 uterine leiomyosarcoma receivingadjuvant chemotherapy by standard-of-care doxorubicin and trabectedin for 6 cycles
Secondary Objectives:
- To assess overall survival (OS) in patients with AJCC stage 1b, 2 and 3 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 AJCC stage 1b, 2 and 3 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 AJCC stage 1b, 2 and 3 uterine leiomyosarcoma receiving adjuvant chemotherapy by standard-of-care doxorubicin and trabectedin for 6 cycles
Exploratory Objectives
- To analyze ctDNA dynamics as a predictor of treatment response and recurrence risk, in patients with AJCC stage 1b, 2 and 3 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
- To assess the feasibility of delivering protocol-specified adjuvant chemotherapy (doxorubicin-trabectedin) using a decentralized clinical trial model.
- To assess patient satisfaction and acceptability of decentralized trial participation based on Study Participant Feedback Questionnaire (SPFQ).
- To compare protocol adherence, data completeness, and safety monitoring fidelity between centralized and decentralized participants.
- To explore the impact of decentralization on patient access, representativeness, and trial retention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phase II Single Arm Treatment with Doxorubicin and Trabectedin | Experimental | Drug: Trabectedin, Drug: Doxorubicin HydrochlorideParticipants will receive treatment on an outpatient and standard of care basis |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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 30 days.
- Patients must have no history of pelvic radiation (hematologic tolerance of chemotherapy is impaired by pelvic radiation)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TrabectedinGiven by IV Infusion | Drug | Phase II Single Arm Treatment with Doxorubicin and Trabectedin |
| Doxorubicin HydrochlorideGiven by IV Infusion | Drug | Phase II Single Arm Treatment with Doxorubicin and Trabectedin |
Primary outcome
Safety and Adverse Events (AEs)
Time frame: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
Related trials for Uterine Leiomyosarcoma
Active, not recruitingPhase 2
Cabozantinib and Temozolomide for the Treatment of Unresectable or Metastatic Leiomyosarcoma or Other Soft Tissue Sarcoma
Metastatic Leiomyosarcoma, Metastatic Soft Tissue Sarcoma
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruitingPhase 2/3
Testing Olaparib and Temozolomide Versus the Usual Treatment for Uterine Leiomyosarcoma After Chemotherapy Has Stopped Working
Locally Advanced Uterine Corpus Leiomyosarcoma, Metastatic Uterine Corpus Leiomyosarcoma
RecruitingPhase 2
Interest of Post-operative Chemotherapy in Patients With Localised Uterine Leiomyosarcoma Suspected of Having a High Risk of Recurrence Based on a Biological Test Performed on the Tumour
Leiomyosarcoma Uterus
Active, not recruitingPhase 2
A Phase II Clinical Trial Evaluating the Combination of Olaparib and Temozolomide for the Treatment of Advanced Uterine Leiomyosarcoma
Stage III Uterine Corpus Leiomyosarcoma AJCC v8, Stage IV Uterine Corpus Leiomyosarcoma AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elise Nassif Haddad, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trabectedin and Doxorubicin Hydrochloride in people with Uterine Leiomyosarcoma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elise Nassif Haddad, MD ((281) 460-0607, efnassif@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Adverse Events (AEs) (time frame: Through study completion; an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.