None listed
Conditions
Interventions
Radiation : This study is a prospective randomized clinical trial designed to compare the efficacy of doxorubicin/trabectedin alone versus doxorubicin/trabectedin combined with radiation therapy in pa
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Age: Female patients aged 19 years or older. Diagnosis: Patients diagnosed with primary advanced, metastatic, or unresectable uterine leiomyosarcoma or soft tissue leiomyosarcoma. Recurrent Disease: Patients diagnosed with recurrent, metastatic, or unresectable uterine leiomyosarcoma or soft tissue leiomyosarcoma. a) No previous systemic therapy (chemotherapy) is allowed. However, patients who have undergone surgical treatment or radiation therapy are eligible. b) If prior radiation therapy was administered, the current lesion must be at a different site from the previous radiation field. If the current lesion is at the same site as the prior radiation, patients may still be eligible if they can tolerate the additional radiation dose required for this study. Measurable Disease: At least one measurable lesion according to RECIST criteria V 1.1. Performance Status: ECOG Performance Status: 0-2 Adequate Organ Function: a) WBC = 3,000/mm³ b) Neutrophils = 1,500/mm³ c) Platelets = 100,000/mm³ d) Creatinine = 2.0 mg/dL e) Bilirubin = 1.5 × institutional upper limit of normal (ULN) f) SGOT, SGPT, and ALP = 3 × institutional upper limit of normal (ULN) g) Normal cardiac function with a left ventricular ejection fraction (LVEF) = 50% as assessed by echocardiogram or MUGA scan. Reproductive Status: Women of childbearing potential must have a negative pregnancy test before participation. Must practice effective contraception before, during, and for 6 months after the study. Informed Consent: Patients must voluntarily sign the informed consent form. Elderly Patients (=80 years): When enrolling patients aged 80 years or older, it is recommended to obtain additional consent from a qualified representative. However, if the elderly patient is able to understand and make independent decisions regarding the study, their voluntary consent alone may be considered sufficient. This should be documented with supporting evidence of the patient's cognitive and physical ability to provide consent.
Exclusion criteria
Exclusion criteria: Histological Type: Patients diagnosed with uterine or soft tissue sarcoma of a histological type other than leiomyosarcoma. Contraindications to Study Drugs: Patients with known contraindications to Trabectedin or Doxorubicin, including: Cardiac contraindications Renal contraindications Hepatic contraindications Hypersensitivity to either drug Prior Systemic Therapy: Patients who have previously received systemic therapy (chemotherapy) for the current disease. Prior Radiation Therapy: Patients who have previously received radiation therapy for the current disease. However, patients may be eligible if the current lesion is located at a different site from the previous radiation field. If the lesion is located at the same site, the patient may still participate if the additional radiation dose required for this study can be safely administered. Central Nervous System (CNS) Metastasis: Patients with metastatic cancer involving the central nervous system. History of Other Cancers: Patients with a history of other cancers within the past 5 years, except for: Non-melanoma skin cancer Cervical carcinoma in situ Superficial cancer of the stomach or bladder Severe Comorbidities or Complications: Patients with severe underlying diseases or serious medical conditions that may interfere with study participation. Pregnancy and Lactation: Pregnant or breastfeeding women are excluded from participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical benefit rate;Duration of response;Progression-free survival;Overall survival;Adverse events;Quality of life | — |
Countries
Korea, Republic of
Contacts
Public ContactJeong-Yeol Park
Asan Medical Center
Outcome results
None listed