Maintenance Pegylated Liposomal Doxorubicin (PLD) Versus Active Surveillance for Advanced Soft Tissue Sarcoma Patients Who Had Controlled Disease After Standard Anthracycline-based Treatment (MELODY)
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
81
pegylated liposomal doxorubicin 40mg / m2 every 4 weeks for a maximum of 12 cycles.
Chang Gung Memorial Hospital
Kaohsiung City, Taiwan
RECRUITINGKaohsiung Medical University Chung-Ho Memorial Hospital,
Kaohsiung City, Taiwan
RECRUITINGChina Medical University Hospital
Taichung, Taiwan
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.
Time frame: Up to approximately 2 years
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
Time frame: Up to approximately 2 years
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 frame: Up to approximately 2 years
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.
Time frame: Up to approximately 2 years
Objective response rate (ORR)
Objective response rate (ORR) at maintenance PLD phase per RECIST 1.1 criteria
Time frame: Up to approximately 2 years
Frequency and severity of AE
AEs will be accessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0).
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National Cheng Kung University Hospital
Tainan, Taiwan
RECRUITINGNational Taiwan University Hospital
Taipei, Taiwan
RECRUITINGTaipei Veterans General Hospital
Taipei, Taiwan
RECRUITINGTri-Service General Hospital
Taipei, Taiwan
RECRUITINGTime frame: Up to approximately 2 years
Safety of interest: cardiac function as assessed by LVEF
Safety of interest: cardiac function as assessed by LVEF(either by cardiac US or MUGA)
Time frame: Up to approximately 2 years
Quality of Life Effects on patient-reported outcomes as assessed by EORTC QLQ C30
The questionnaire comprises 5 functioning scales (physical, role, emotional, cognitive, and social functioning), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties), and a global health status/QoL scale. The functioning and symptoms items are scored on a 4-point scale that range from "not at all" to "very much," and the global health status and QoL items are scored on a 7-point scale that ranges from "very poor" to "excellent.". There are 30 questions in total and the scores range from 0 to 100.
Time frame: Up to approximately 2 years