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.
Parallel
Pegylated liposomal doxorubicin
Drugpegylated liposomal doxorubicin 40mg / m2 every 4 weeks for a maximum of 12 cycles.
Progression-free survival from randomization
The Tumor response will be assessed according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1, see Appendix 2) every 8 weeks, and every 12 weeks 24 weeks after randomization.
Overall survival (OS)
Defined as the time from the date of randomization to the date of death from any cause, or censoring at the date of last known follow-up alive
Progression-free survival (PFS)
Progression-free survival (PFS) rate at 12 months. PFS is defined as the time from the date of randomization to the date of first documented evidence of progressive disease (including radiograph or clinical progressive disease), or death, whichever occurs first.
Time to next treatment (TTNT)
Defined as the time from the date of randomization to the date of commencing next treatment line. Patients who started other anti-cancer therapy (including radiotherapy and surgery) will be counted as an event for TTNT. Those who received radiotherapy or surgical resection after randomization but not based on clinical or radiological progression are considered as an event for TTNT.
Objective response rate (ORR)
Objective response rate (ORR) at maintenance PLD phase per RECIST 1.1 criteria
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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
