RecruitingPhase 2NCT06981637

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)


Sponsor

National Health Research Institutes, Taiwan

Enrollment

81 participants

Start Date

Dec 31, 2025

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two approaches after first-line chemotherapy (anthracycline-based treatment) for advanced soft tissue sarcoma: continuing with a second chemotherapy drug (pegylated liposomal doxorubicin, or PLD) versus active surveillance (watchful waiting without immediate further treatment). It is for patients whose cancer did not worsen during initial chemotherapy. **You may be eligible if...** - You are 18 or older with a confirmed advanced soft tissue sarcoma - Your cancer responded to or remained stable during 4 to 8 cycles of first-line anthracycline-based chemotherapy - Your cancer can still be measured on scans (per standard criteria) - You can be enrolled within 8 weeks of your last chemotherapy dose - You are in reasonably good health **You may NOT be eligible if...** - Your sarcoma is a subtype that typically does not respond to chemotherapy (e.g., alveolar soft part sarcoma, clear cell sarcoma, solitary fibrous tumor) - You have significant heart disease (prior anthracyclines can affect heart function) - You have progressive or worsening disease after first-line treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPegylated liposomal doxorubicin

pegylated liposomal doxorubicin 40mg / m2 every 4 weeks for a maximum of 12 cycles.


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

View Full Details on ClinicalTrials.gov

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NCT06981637


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