Study on efficacy of doxorubicin and trabectedin combination therapy

JRCT ID: jRCTs061240064

Registered date:08/10/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Soft tissue sarcoma
• Date of first enrollment: 08/10/2024
• Target sample size: 15
• Study type: Interventional
• Intervention(s): Doxorubicin (60 mg/m2) for 15 minutes, Trabectidin (1.1 mg/m2) for 3 hours via central venous catheter

Outcome(s)

• Primary Outcome: Disease control rate
• Secondary Outcome: Progression-free survival, Duration Of Response, Overall survival, Adverse events

Key inclusion & exclusion criteria

• Age minimum: > 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Patients with pathologically diagnosed malignant soft tissue tumors whose primary tumor or distant metastases are considered unresectable. Patients with recurrent or metastatic lesions do not necessarily require histological confirmation of the diagnosis of recurrent disease. The histological type is also not required.
2. Patients with target lesions that can be evaluated by imaging studies.
3. Patients who have obtained written consent from the subject of the study.
4. Patients who are at least 18 years of age at the time consent is obtained.

Exclude criteria

1. Patients who have received a cumulative dose of doxorubicin of 120 mg/m2 or more.
2. Patients with a performance status of 3 or higher.
3. Patients with serious hematological abnormalities (neutrophil count < 1500/uL, hemoglobin < 9.0 g/uL, platelet count < 10*104/uL).
4. Patients with serious hepatic dysfunction (total bilirubin > 1.5 mg/dL, AST, ALT, ALP > 2.5 times the institutional reference value)
5. Patients with serious renal dysfunction (creatinine kinase>2.5 times the institutional reference value, creatinine clearance < 30 mL/min).
6. Patients with serious cardiac dysfunction (left ventricular ejection fraction less than 45%).
7. Women who are pregnant, may become pregnant, or wish to have a baby.
8. Patients who are participating or intend to participate in other clinical studies while participating in this study.
9. If participation in the research is not in the best interest of the research subject or is deemed to interfere with the evaluation specific to the clinical research protocol.
10. An employee of the Principal Investigator or other health care provider directly involved in this or other clinical research, or a family member of such an employee or Principal Investigator.
11. Patients for whom the attending physician is deemed inappropriate.

Related Information

• Primary Sponsor: Fujibuchi Taketsugu