NCT06981637招募中2 期
Maintenance Pegylated Liposomal Doxorubicin (PLD) Versus Active Surveillance for Advanced Soft Tissue Sarcoma Patients Who Had Controlled Disease After Standard Anthracycline-based Treatment (MELODY)
National Health Research Institutes, Taiwan9 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2025年12月31日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 81
- 试验地点
- 9
- 主要终点
- Progression-free survival from randomization
研究概览
简要总结
Maintenance Pegylated Liposomal Doxorubicin (PLD) Versus Active Surveillance for Advanced Soft Tissue Sarcoma Patients Who Had Controlled Disease After Standard Anthracycline-based Treatment (MELODY)
详细描述
Patients enrolled will be randomized to either experimental arm or control arm. Patients in experimental arm will receive pegylated liposomal doxorubicin (PLD) 40mg/m2 every 4 weeks. Maintenance PLD could be administered up to a total of 12 cycles. Patients in control arm will receive active surveillance without treatment (treatment holiday).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A histologically confirmed advanced soft tissue sarcoma. Note that subtypes typically do not use chemotherapy as standard treatment are not allowed, such as alveolar soft part sarcoma, solitary fibrous tumor, extraskeletal myxoid chondrosarcoma, clear cell sarcoma)
- •Patients received first-line anthracycline-based treatment for a minimum of 4 cycles and a maximum of 8 cycles.
- •The best response after first-line anthracycline-based treatment must be either a complete response, partial response, or stable disease as defined by RECIST 1.
- •The best response should be attributed solely to systemic treatment and not to local therapy. All the patients must have at least one measurable tumor based on RECIST 1.1 before initiating first-line anthracycline-based treatment.
- •Patients must be randomized within 8 weeks of their last dose of anthracycline-based treatment
- •Patients have a life expectancy ≥ 3 months
- •Patients older than 18 years old.
- •ECOG performance status of 0 to
- •Patients must have adequate organ function and marrow reserve measured within 7 days prior to randomization as defined below:
- •Hemoglobin ≥ 9.0 g/dL;
- •Absolute neutrophil count ≥ 1,500/mm3;
- •Platelets ≥ 100,000/mm3;
- •Total bilirubin ≤ 1.5 x upper normal limit;
- •AST(SGOT)/ALT(SGPT) ≤ 2.5 x upper normal limit; for patients with liver metastases AST(SGOT)/ALT(SGPT) ≤ 5 x upper normal limit is allowed;
- •Serum creatinine ≤ 1.5mg/dL or creatinine clearance ≥50ml/min;
- •All women of childbearing potential must have a negative pregnancy test obtained within 72 hours before starting therapy.
- •For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm.
- •Patients with reproductive potential must use effective contraception (hormone orbarrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 6 months after the completion of therapy.
- •Patients must be able to comply with study procedures and sign informed consent.
排除标准
- •Known allergy history to PLD or other drugs of liposome-based formulation.
- •LVEF < 50% at screening as determined by UCG or MUGA.
- •Serious non-healing wound, ulcer, or bone fracture not related to underlying sarcoma.
- •Major surgical procedure, open biopsy, significant traumatic injury, or radiotherapy within 21 days prior to randomization.
- •Severe, uncontrolled medical conditions including severe liver disease, heart disease, uncontrolled diabetes or hypertension, or pulmonary disease.
- •Psychiatric illness or social situation that would preclude study compliance.
- •Women with pregnant or breast feeding (a urine pregnancy test must be performed on all female patients who are of childbearing potential before entering the study, and the result must be negative.
- •Another previous malignancy diagnosed within the past 3 years. Patients with carcinoma in situ and stage I malignancy under active surveillance (no medical treatment needed) are allowed for enrollment.
- •Active CNS metastasis defined by clinical symptoms, cerebral edema, steroid or anti- convulsant requirement, or progressive growth. Patients with a history of CNS metastasis or cord compression are allowed in the study if they have been treated and are clinically stable.
- •Patients with active hepatitis B. However, patients with controlled hepatitis B under anti-viral agent are allowed.
研究组 & 干预措施
Pegylated liposomal doxorubicin
Experimental
Patients in experimental arm will receive pegylated liposomal doxorubicin (PLD) 40mg/m2 every 4 weeks. Maintenance PLD could be administered up to a total of 12 cycles.
干预措施: Pegylated liposomal doxorubicin (Drug)
结局指标
主要结局
Progression-free survival from randomization
时间窗: Up to approximately 2 years
The Tumor response will be assessed according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1, see Appendix 2) every 8 weeks, and every 12 weeks 24 weeks after randomization.
次要结局
- Overall survival (OS)(Up to approximately 2 years)
- Progression-free survival (PFS)(Up to approximately 2 years)
- Time to next treatment (TTNT)(Up to approximately 2 years)
- Objective response rate (ORR)(Up to approximately 2 years)
- Frequency and severity of AE(Up to approximately 2 years)
- Safety of interest: cardiac function as assessed by LVEF(Up to approximately 2 years)
- Quality of Life Effects on patient-reported outcomes as assessed by EORTC QLQ C30(Up to approximately 2 years)
研究者
研究点 (9)
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