Phase II decentralized adjuvant doxorubicin plus trabectedin for uterine leiomyosarcoma
Phase II Decentralized Pragmatic Trial of Adjuvant Doxorubicin - Trabectedin Chemotherapy in Uterine Leiomyosarcoma
This trial will try whether six cycles of doxorubicin plus trabectedin after surgery can prolong the time patients with stage 1b or 2 uterine leiomyosarcoma remain cancer-free.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, radiation, doxorubicin |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT07076186 on ClinicalTrials.gov |
What this trial studies
This is a Phase II interventional trial giving six cycles of standard-of-care doxorubicin combined with trabectedin as adjuvant chemotherapy after complete surgical resection for localized uterine leiomyosarcoma. The primary endpoint is disease-free survival, with secondary endpoints including overall survival, treatment-related toxicity, patient-reported quality of life, ctDNA dynamics, and incidence of germline alterations. Eligible patients must be adults with histologically confirmed uLMS who had a complete resection (at least total hysterectomy) within three months and no residual disease on recent CT. The protocol is led by The University of Texas M. D. Anderson Cancer Center.
Who should consider this trial
Good fit: Adults (≥18) with histologically confirmed uterine leiomyosarcoma who had complete surgical resection (at least a total hysterectomy) within 3 months and no residual disease on chest/abdomen/pelvic CT, typically with FIGO/AJCC stage 1b–2.
Not a fit: Patients with residual or metastatic disease, prior pelvic radiation or prior chemotherapy for uLMS, and children under 18 are unlikely to be eligible or to benefit from this adjuvant regimen.
Why it matters
Potential benefit: If successful, this regimen could lengthen cancer-free survival after surgery for patients with localized uterine leiomyosarcoma.
How similar studies have performed: Doxorubicin and trabectedin each have shown activity in advanced or metastatic leiomyosarcoma, but their combined use as adjuvant therapy in localized uLMS has not been well tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 * 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. Exclusion Criteria: * 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.
Where this trial is running
Houston, Texas
- The University of Texas M. D. Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Elise Nassif Haddad, MD — M.D. Anderson Cancer Center
- Study coordinator: Elise Nassif Haddad, MD
- Email: efnassif@mdanderson.org
- Phone: (281) 460-0607
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.