NCT06981637

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)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 81 (estimated)
• Sponsor: National Health Research Institutes, Taiwan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Advanced Soft Tissue Sarcoma

Interventions

Type	Name	Description
DRUG	Pegylated liposomal doxorubicin	pegylated liposomal doxorubicin 40mg / m2 every 4 weeks for a maximum of 12 cycles.

Timeline

• Start date: 2025-12-31
• Primary completion: 2028-07-31
• Completion: 2029-07-31
• First posted: 2025-05-21
• Last updated: 2026-01-20

Locations

7 sites across 1 country: Taiwan