Actively Recruiting
Pegylated Liposomal Doxorubicin (PLD) Versus Active Surveillance for Advanced Soft Tissue Sarcoma Patients Who Had Controlled Disease After Standard Anthracycline-based Treatment (MELODY)
Led by National Health Research Institutes, Taiwan · Updated on 2026-01-20
81
Participants Needed
7
Research Sites
186 weeks
Total Duration
On this page
Sponsors
N
National Health Research Institutes, Taiwan
Lead Sponsor
N
National Taiwan University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Maintenance Pegylated Liposomal Doxorubicin (PLD) Versus Active Surveillance for Advanced Soft Tissue Sarcoma Patients Who Had Controlled Disease After Standard Anthracycline-based Treatment (MELODY)
CONDITIONS
Official Title
Pegylated Liposomal Doxorubicin (PLD) Versus Active Surveillance for Advanced Soft Tissue Sarcoma Patients Who Had Controlled Disease After Standard Anthracycline-based Treatment (MELODY)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed advanced soft tissue sarcoma, excluding subtypes like alveolar soft part sarcoma, solitary fibrous tumor, extraskeletal myxoid chondrosarcoma, and clear cell sarcoma
- Received 4 to 8 cycles of first-line anthracycline-based treatment
- Best response after anthracycline treatment is complete response, partial response, or stable disease by RECIST 1.1, attributed only to systemic treatment
- At least one measurable tumor before starting anthracycline treatment
- Randomized within 8 weeks after last anthracycline dose
- Life expectancy of 3 months or more
- Age older than 18 years
- ECOG performance status 0 or 1
- Adequate organ function and marrow reserve within 7 days prior to randomization, including hemoglobin ≥ 9.0 g/dL, neutrophils ≥ 1,500/mm3, platelets ≥ 100,000/mm3, total bilirubin ≤ 1.5 x upper limit, AST/ALT ≤ 2.5 x upper limit (≤ 5 x if liver metastases), creatinine ≤ 1.5 mg/dL or creatinine clearance ≥ 50 ml/min
- Negative pregnancy test for women of childbearing potential within 72 hours before therapy
- Male participants agree to abstain from heterosexual intercourse or use condoms and refrain from sperm donation
- Patients with reproductive potential use effective contraception during and for 6 months after study
- Ability to comply with study procedures and provide informed consent
You will not qualify if you...
- Known allergy to pegylated liposomal doxorubicin or liposome-based drugs
- Left ventricular ejection fraction (LVEF) below 50% at screening
- Serious non-healing wounds, ulcers, or bone fractures not related to sarcoma
- Major surgery, open biopsy, significant injury, or radiotherapy within 21 days before randomization
- Severe uncontrolled medical conditions including liver disease, heart disease, uncontrolled diabetes, hypertension, or pulmonary disease
- Psychiatric illness or social situation preventing compliance
- Pregnant or breastfeeding women
- Another malignancy diagnosed within the past 3 years except carcinoma in situ or stage I malignancy under active surveillance
- Active central nervous system metastasis with symptoms or requiring steroids/anti-convulsants; stable treated CNS metastasis allowed
- Active hepatitis B infection; controlled hepatitis B under antiviral treatment allowed
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Chang Gung Memorial Hospital
Kaohsiung City, Taiwan
Not Yet Recruiting
2
Kaohsiung Medical University Chung-Ho Memorial Hospital,
Kaohsiung City, Taiwan
Actively Recruiting
3
China Medical University Hospital
Taichung, Taiwan
Actively Recruiting
4
National Cheng Kung University Hospital
Tainan, Taiwan
Actively Recruiting
5
National Taiwan University Hospital
Taipei, Taiwan
Actively Recruiting
6
Taipei Veterans General Hospital
Taipei, Taiwan
Actively Recruiting
7
Tri-Service General Hospital
Taipei, Taiwan
Actively Recruiting
Research Team
T
Tsang-Wu Liu, MD
CONTACT
T
Tom Wei-Wu Chen, MD,PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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