Phase II Decentralized Pragmatic Trial of Adjuvant Doxorubicin - Trabectedin Chemotherapy in uLMS (NCT07076186) | Clinical Trial Compass
RecruitingPhase 2
Phase II Decentralized Pragmatic Trial of Adjuvant Doxorubicin - Trabectedin Chemotherapy in uLMS
United States48 participantsStarted 2025-10-02
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
Safety and Adverse Events (AEs)
Timeframe: Through study completion; an average of 1 year