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Pegylated Liposomal Doxorubicin (PLD) Versus Active Surveillance for Advanced Soft Tissue Sarcoma Patients Who Had Controlled Disease After Standard Anthracycline-based Treatment (MELODY) | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Pegylated Liposomal Doxorubicin (PLD) Versus Active Surveillance for Advanced Soft Tissue Sarcoma Patients Who Had Controlled Disease After Standard Anthracycline-based Treatment (MELODY)

Maintenance Pegylated Liposomal Doxorubicin (PLD) Versus Active Surveillance for Advanced Soft Tissue Sarcoma Patients Who Had Controlled Disease After Standard Anthracycline-based Treatment (MELODY)

NCT06981637•National Health Research Institutes, Taiwan

View on ClinicalTrials.gov

Summary

Maintenance Pegylated Liposomal Doxorubicin (PLD) Versus Active Surveillance for Advanced Soft Tissue Sarcoma Patients Who Had Controlled Disease After Standard Anthracycline-based Treatment (MELODY)

Detailed Description

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 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)
•2. Patients received first-line anthracycline-based treatment for a minimum of 4 cycles and a maximum of 8 cycles.
•3. The best response after first-line anthracycline-based treatment must be either a complete response, partial response, or stable disease as defined by RECIST 1.1.
•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.
•4. Patients must be randomized within 8 weeks of their last dose of anthracycline-based treatment
•5. Patients have a life expectancy ≥ 3 months
•6. Patients older than 18 years old.
•7. ECOG performance status of 0 to 1.
•8. Patients must have adequate organ function and marrow reserve measured within 7 days prior to randomization as defined below:
•1. Hemoglobin ≥ 9.0 g/dL;
+9 more criteria

Exclusion Criteria

•1. Known allergy history to PLD or other drugs of liposome-based formulation.
•2. LVEF \< 50% at screening as determined by UCG or MUGA.
•3. Serious non-healing wound, ulcer, or bone fracture not related to underlying sarcoma.
•4. Major surgical procedure, open biopsy, significant traumatic injury, or radiotherapy within 21 days prior to randomization.
•5. Severe, uncontrolled medical conditions including severe liver disease, heart disease, uncontrolled diabetes or hypertension, or pulmonary disease.
•6. Psychiatric illness or social situation that would preclude study compliance.
•7. 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.
•8. 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.
•9. 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.
•10. Patients with active hepatitis B. However, patients with controlled hepatitis B under anti-viral agent are allowed.

Locations (7)

Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital,

Kaohsiung City, Taiwan

China Medical University Hospital

Taichung, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Tri-Service General Hospital

Taipei, Taiwan

Key Dates

Start Date

December 31, 2025

Primary Completion Date

July 31, 2028

Completion Date

July 31, 2029

Last Updated

January 20, 2026

Enrollment

ESTIMATED participants

Conditions

Advanced Soft Tissue Sarcoma

Interventions

Pegylated liposomal doxorubicin

DRUG

Contacts

Tsang-Wu Liu, MD

CONTACT

+886-2-26534401 walter@nhri.org.tw

Tom Wei-Wu Chen, MD,PhD

CONTACT

+886-2-23123456 tomweiwuchen@ntu.edu.tw

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 20, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Pegylated Liposomal Doxorubicin (PLD) Versus Active Surveillance for Advanced Soft Tissue Sarcoma Patients Who Had Controlled Disease After Standard Anthracycline-based Treatment (MELODY)

Inclusion Criteria

Exclusion Criteria

Actinium Therapy for Late-stage Aggressive Sarcomas

SAINT:Trabectedin, Ipilimumab and Nivolumab for Previously Treated Advanced Soft Tissue Sarcoma

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