Maintenance Pegylated Liposomal Doxorubicin (PLD) Versus Active Surveillance for Advanced Soft Tissue Sarcoma Patients Who Had Controlled Disease After Standard Anthracycline-based Treatment (MELODY)
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 1.1.
Patients must be randomized within 8 weeks of their last dose of anthracycline-based treatment
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.
National Health Research Institutes, Taiwan
Lead sponsor
National Taiwan University Hospital
Collaborator
Chang Gung Memorial Hospital
Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital
Collaborator
Taipei Veterans General Hospital, Taiwan
Collaborator
National Cheng-Kung University Hospital
Collaborator
Tri-Service General Hospital (TSGH)
Collaborator
China Medical University Hospital
Collaborator