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

RecruitingPhase 2Ages 18 Years - anyFemaleM.D. Anderson Cancer Center
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In plain words

What the trial is, and whether it could suit you

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.

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๐Ÿ“‹ Eligibility rules (as published)
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 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 * Age โ‰ฅ18 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 โ‰ค2 (Karnofsky โ‰ฅ60%,). * Patients must have adequate organ and marrow function as defined below: * absolute neutrophil count โ‰ฅ1,000/mcL * platelets โ‰ฅ100,000/mcL * total bilirubin โ‰ค 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) โ‰ค2ร— institutional ULN * eGFR (using 2021 CKD-EPI) โ‰ฅ40mL/min/1.73m2 * Albumin \> 28 g/L * CPK โ‰ค2ร— 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.
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What it tests

  • Trabectedin
  • Doxorubicin Hydrochloride
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Where

1 site
The University of Texas M. D. Anderson Cancer Center
Houston, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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