A phase II study for neoadjuvant chemotherapy (doxorubicin and ifosfamide) treatment in patients with retroperitoneal de-differentiated liposarcoma; a prospective, single-arm study.

Kurimoto Keisuke0 sites23 target enrollmentStarted: April 14, 2023Last updated: October 17, 2023

Trial Snapshot

No summary available.

•The patients diagnosed with de-differentiated liposarcoma diagnosed by a pathologist
•The patients diagnosed with de-differentiated liposarcoma by clinical findings and radiological findings if preoperative biopsy is not possible
•The patients with a diagnosis of dedifferentiated liposarcoma in the tissue specimen from the previous surgery at the time of recurrence
•The patients who have no metastasis (M0) based on the UICC 8th edition
•The patients who are scheduled to undergo en bloc resection (R0/1)
•The patients' age is over 18 years or older at the time of obtaining consent
•ECOG Performance status 0 or 1
•No active multiple cancer at the same time
•Latest laboratory data within 14 days prior to enrollment
•1 White blood cell count over 3,000/mm3
•2 Neutrophil count over 15,000/mm3
•3 Hemogrlobin over 9.0g/dL
•4 Platelet count over 100,000/mm3
•5 Total bilirubin under 1.5mg/dL
•6 AST under 100IU/L
•7 ALT under 100IU/L
•8 Serum creatinine under 1.2 mg/dL, however, Creatinine clearance (CCr) over 50mL/min is met.
•9 Ejection-fraction ratio over 45 measured by cardiac ultrasound

•The patients have a severe allergy and drug hypersensitivity
•The patients with a history of anthracycline use whose lifetime cumulative dose is expected to exceed 500 mg/ m2 after doxoribicin conversion during the current study
•The patient has active multiple cancers
•The patient has a systemic active infection that requires treatment
•The patient has ascites and pleural effusion that is uncontrollable
•The patient has a systemic fever (over 38.0 degrees)
•Pregnant women, lactating women, women who may be currently pregnant or women who are within 28 days after childbirth
•Men who want the partner's pregnancy
•Clinically problematic psychiatric disorders that would make enrollment in this study difficult
•The patient has systemic steroids and immunosuppressive drugs
•The patient has the following complication
•1 uncontrollable diabetes
•2 uncontrollable hypertension
•3 unstable angina pectoris
•4 uncontrollable vascular disease, idiopathic dilated cardiomyopathy, hypertrophic cardiomyopathy and heart failure
•5 liver cirrosis
•6 renal failure
•7 intersitial pneumonia. Pulmonary fibrosis and emphysema
•Other cases deemed inapporopriate by the physician in charge

Sponsor

Kurimoto Keisuke