NIPH Clinical Trials Search

A feasibility study of doxorubicin plus trabectedin combination therapy for leiomyosarcoma

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Leiomyosarcoma
Date of first enrollment	23/05/2025
Target sample size	10
Countries of recruitment
Study type	Interventional
Intervention(s)	Doxorubicin + Trabectedin Combination Therapy 1. Dexamethasone 16.5 mg IV drip as premedication 30 minutes before the start of doxorubicin 2. Doxorubicin 60 mg/m2 IV drip 3. Trabectedin 1.1 mg/m2 IV drip via central vein over 3 hours 4. Long-acting G-CSF pegfilgrastim 3.6 mg subcutaneous injection the next day Administer up to 6 courses every 3 weeks. Trabectedin Maintenance Therapy 1. Dexamethasone 16.5 mg IV drip as premedication 30 minutes before the start of trabectedin 2. Trabectedin 1.1 mg/m2 IV drip via central vein over 3 hours Administer every 3 weeks.

Outcome(s)

Primary Outcome	Completion rate of 6 courses of doxorubicin + trabectedin therapy.
Secondary Outcome	Time to treatment failure, progression-free survival, overall survival, response rate, incidence of adverse events, incidence of Grade 3 or higher adverse events, incidence of Grade 4 or higher hematologic toxicity, incidence of febrile neutropenia, rate of tumor resection after study treatment

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	Patients must meet all of the following criteria: (1) Histopathologically confirmed diagnosis of leiomyosarcoma (2) No prior history of chemotherapy for leiomyosarcoma (3) Patients with locally advanced tumor diagnosed as unresectable by consultation with a surgeon, patients with distant metastasis, or patients of recurrence after surgical resection (4) Age: 18 years or older (5) ECOG performance status: 0 or 1 (6) No concurrent active malignancy. However, eligibility is allowed if the leiomyosarcoma is predicted to determine the prognosis, such as when other malignancies are early-stage cancers or slowly growing lesions. (7) Neutrophil count >= 1,500/mm3 (8) Hemoglobin >= 9.0 g/dL (allowing for increases due to blood transfusion) (9) Platelet count >= 100,000/mm3 (10) Albumin >= 2.5 g/dL (11) Creatinine clearance (calculated using the Cockcroft-Gault formula) >= 30 mL/min <Cockcroft-Gault formula> Ccr (mL/min) = Weight (kg) x (140 - Age) / (72 x Serum creatinine level (mg/dL)) For women, multiply the obtained value by 0.85. (12) Serum bilirubin <= 1.5 mg/dL (13) ALT <= 2.5 x the upper limit of the institutional normal range (14) AST <= 2.5 x the upper limit of the institutional normal range (15) ALP <= 2.5 x the upper limit of the institutional normal range (unless caused by the primary disease) (16) Left ventricular ejection fraction (LVEF) on echocardiography >= 50% (17) Creatine phosphokinase (CPK) <= 2.5 x the upper limit of the institutional normal range (18) Written informed consent obtained (19) In the case of women of childbearing potential, appropriate contraception (oral contraceptives (progestin/estrogen combination), intrauterine device, or male partner's condom) must be used during trabectedin administration and for 7 months after the final dose. (20) In the case of men, condoms must be used for contraception during trabectedin administration and for 4 months after the final dose.
Exclude criteria	Patients who meet any of the following criteria should not be included in this study: (1) History of treatment with anthracycline-based drugs or trabectedin. (2) Pregnant or potentially pregnant patients, and breastfeeding patients. (3) Other patients deemed inappropriate by the principal investigator or sub-investigator.