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A feasibility study of doxorubicin plus trabectedin combination therapy for leiomyosarcoma

A feasibility study of doxorubicin plus trabectedin combination therapy for leiomyosarcoma

Maeda Osamu

Nagoya University Hospital

65 Tsurumai-cho, Showa-ku, Nagoya, Aichi Prefecture

maeda.osamu.s2@f.mail.nagoya-u.ac.jp

Maeda Osamu

Nagoya University Hospital

65 Tsurumai-cho, Showa-ku, Nagoya, Aichi Prefecture

+81-52-744-1903

maeda.osamu.s2@f.mail.nagoya-u.ac.jp

Recruiting

May. 23, 2025

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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.

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.

Both

Leiomyosarcoma

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.

Completion rate of 6 courses of doxorubicin + trabectedin therapy.

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

+81-52-744-2479

April. 30, 2025

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