Pegylated Liposomal Doxorubicin (PLD) Versus Active Surveillance for Advanced Soft Tissue Sarcoma Patients Who Had Controlled Disease After Standard Anthracycline-based Treatment (MELODY)

NCT ID: NCT06981637

Last Updated: 2026-01-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2029-07-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pegylated liposomal doxorubicin

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.

Group Type: EXPERIMENTAL

Pegylated liposomal doxorubicin

Intervention Type: DRUG

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

Active surveillance

Patients in control arm will receive active surveillance without treatment (treatment holiday). In control arm, crossover is not permitted after disease progression

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Pegylated liposomal doxorubicin

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

Intervention Type: DRUG

Other Intervention Names

Lipodox

Eligibility Criteria

Inclusion Criteria

1. 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)

2. Patients received first-line anthracycline-based treatment for a minimum of 4 cycles and a maximum of 8 cycles.

3. 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.

The best response should be attributed solely to systemic treatment and not to local therapy. All the patients must have at least one measurable tumor based on RECIST 1.1 before initiating first-line anthracycline-based treatment.

4. Patients must be randomized within 8 weeks of their last dose of anthracycline-based treatment

5. Patients have a life expectancy ≥ 3 months

6. Patients older than 18 years old.

7. ECOG performance status of 0 to 1.

8. Patients must have adequate organ function and marrow reserve measured within 7 days prior to randomization as defined below:

1. Hemoglobin ≥ 9.0 g/dL;

2. Absolute neutrophil count ≥ 1,500/mm3;

3. Platelets ≥ 100,000/mm3;

4. Total bilirubin ≤ 1.5 x upper normal limit;

5. AST(SGOT)/ALT(SGPT) ≤ 2.5 x upper normal limit; for patients with liver metastases AST(SGOT)/ALT(SGPT) ≤ 5 x upper normal limit is allowed;

6. Serum creatinine ≤ 1.5mg/dL or creatinine clearance ≥50ml/min;

7. All women of childbearing potential must have a negative pregnancy test obtained within 72 hours before starting therapy.

9. For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm.

10. Patients with reproductive potential must use effective contraception (hormone orbarrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 6 months after the completion of therapy.

11. Patients must be able to comply with study procedures and sign informed consent.

Exclusion Criteria

1. Known allergy history to PLD or other drugs of liposome-based formulation.

2. LVEF < 50% at screening as determined by UCG or MUGA.

3. Serious non-healing wound, ulcer, or bone fracture not related to underlying sarcoma.

4. Major surgical procedure, open biopsy, significant traumatic injury, or radiotherapy within 21 days prior to randomization.

5. Severe, uncontrolled medical conditions including severe liver disease, heart disease, uncontrolled diabetes or hypertension, or pulmonary disease.

6. Psychiatric illness or social situation that would preclude study compliance.

7. Women with pregnant or breast feeding (a urine pregnancy test must be performed on all female patients who are of childbearing potential before entering the study, and the result must be negative.

8. Another previous malignancy diagnosed within the past 3 years. Patients with carcinoma in situ and stage I malignancy under active surveillance (no medical treatment needed) are allowed for enrollment.

9. Active CNS metastasis defined by clinical symptoms, cerebral edema, steroid or anti- convulsant requirement, or progressive growth. Patients with a history of CNS metastasis or cord compression are allowed in the study if they have been treated and are clinically stable.

10. Patients with active hepatitis B. However, patients with controlled hepatitis B under anti-viral agent are allowed.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: collaborator

Chang Gung Memorial Hospital

OTHER

Sponsor Role: collaborator

Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role: collaborator

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role: collaborator

National Cheng-Kung University Hospital

OTHER

Sponsor Role: collaborator

Tri-Service General Hospital

OTHER

Sponsor Role: collaborator

China Medical University Hospital

OTHER

Sponsor Role: collaborator

National Health Research Institutes, Taiwan

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tsang-Wu Liu, MD

Role: STUDY_DIRECTOR

Taiwan Cooperative Oncology Group, National Health Research Institutes

Tom Wei-Wu Chen, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

Site Status: NOT_YET_RECRUITING

Kaohsiung Medical University Chung-Ho Memorial Hospital,

Kaohsiung City, , Taiwan

Site Status: RECRUITING

China Medical University Hospital

Taichung, , Taiwan

Site Status: RECRUITING

National Cheng Kung University Hospital

Tainan, , Taiwan

Site Status: RECRUITING

National Taiwan University Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Tri-Service General Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Tsang-Wu Liu, MD

Role: CONTACT

walter@nhri.org.tw

+886-2-26534401 ext. 25150

Tom Wei-Wu Chen, MD,PhD

Role: CONTACT

tomweiwuchen@ntu.edu.tw

+886-2-23123456 ext. 267462

Facility Contacts

Yu-Li Su, MD

Role: primary

Yi-Chang Liu, MD

Role: primary

Li-Yaun Bai, M.D.PhD

Role: primary

Chia-Jui Yen, MD,PhD

Role: primary

Tom Wei-Wu Chen, MD,PhD

Role: primary

tomweiwuchen@ntu.edu.tw

Chueh-Chuan Yen, MD,PhD

Role: primary

Ming-Shen Dai, MD

Role: primary

Other Identifiers

T1725

Identifier Type: -

Identifier Source: org_study_id