None listed
Conditions
Interventions
Radiation : The interventions in this study are divided into two groups:
Trabectedin Monotherapy Group (Control Group)
Trabectedin + Low-Dose Radiation Therapy Group (Intervention Group)
1. Trabect
dose re-escalation is not permitted
Dose Delay:
Postpone treatment if hematologic parameters do not meet the required criteria (maximum delay of 4 weeks)
2. Trabectedin + Low-Dose Radiation Therapy
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: (A) Inclusion Criteria: Participants in the study must meet all of the following inclusion criteria: Age and Gender: Female patients aged 19 years or older. Disease Characteristics: Diagnosed with recurrent, metastatic, or advanced soft tissue sarcoma that is unresectable by complete surgical excision. Previous Systemic Therapy: Progressed after at least one prior systemic therapy (chemotherapy), or relapsed after prior systemic therapy. Prior Doxorubicin Treatment: Must have received at least one prior regimen including doxorubicin. Histological Subtypes: Participants must have one of the following histological subtypes: a) Leiomyosarcoma (uterine and extrauterine) b) Liposarcoma (uterine and extrauterine) c) PEComa (uterine and extrauterine) d) High-grade endometrial stromal sarcoma e) Undifferentiated uterine sarcoma Measurable Disease: Must have at least one measurable lesion according to RECIST criteria version 1.1. Performance Status: ECOG performance status of 0 to 2. Adequate Organ Function: Participants must have adequate organ function as defined by the following laboratory criteria: a) White Blood Cell (WBC) count = 3,000/mm³ b) Absolute Neutrophil Count (ANC) = 1,500/mm³ c) Platelet count = 100,000/mm³ d) Serum Creatinine = 2.0 mg/dL e) Total Bilirubin = 1.5 × institutional upper limit of normal (ULN) f) Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), and Alkaline Phosphatase (ALP) = 3 × institutional ULN g) Cardiac Function: Normal cardiac function with a Left Ventricular Ejection Fraction (LVEF) = 50% as assessed by echocardiogram or MUGA scan. Reproductive Potential: Women of childbearing potential must undergo a pregnancy test prior to enrollment and confirm a negative result. Participants must agree to use effective contraception before entering the study, during the study, and for 6 months after completion of the study. Informed Consent: Must voluntarily sign the informed consent form after receiving adequate information about the study. Additional Consent for Elderly Participants: If participants are aged 80 years or older, consent from a legally authorized representative (LAR) should be obtained as a general rule. However, if an elderly participant is determined to be cognitively and physically capable of understanding and making informed decisions, their voluntary consent alone may suffice. In such cases, the assessment of the participant’s cognitive and physical condition must be documented in the relevant study records.
Exclusion criteria
Exclusion criteria: Participants must not meet any of the following exclusion criteria: Previous Trabectedin Treatment: : 1) trabectedin 2) Trabectedin (cardiac, renal, hepatic contraindication hypersensitivity) 3) (, , ) 4) 5) 5 , , 6) 7) Patients who have previously received trabectedin for the same disease. Contraindications to Trabectedin: Patients with cardiac, renal, or hepatic contraindications or known hypersensitivity to trabectedin. Prior Radiation Therapy: Patients who have previously received radiation therapy for the current disease. However, if the site of prior radiation differs from the site to be treated in this study, or if the same site can safely receive the additional radiation dose required in this study, the patient may be eligible. Central Nervous System (CNS) Metastasis: Patients with metastatic cancer involving the CNS. History of Other Cancers: Patients with a history of other malignancies within the past 5 years, except for: Non-melanoma skin cancer Carcinoma in situ of the cervix Superficial cancers of the stomach or bladder Severe Underlying Diseases or Complications: Patients with serious underlying medical conditions or complications that may interfere with the study protocol or pose an unacceptable risk to the patient. Pregnancy and Lactation: Pregnant or breastfeeding women are excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate;Progression-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Benefit Rate ;Duration of Response;Overall Survival (OS);Adverse Events (AEs);Quality of Life (QoL) | — |
Countries
Korea, Republic of
Contacts
Public ContactJeong-Yeol Park
Asan Medical Center
Outcome results
None listed