Retroperitoneal de-differentiated liposarcoma retroperitoneal de-differentiated liposarcoma
Conditions
Interventions
Doxorubicin (20mg/m2/day), IV, given on day1-3 and ifosfamide (2g/m2/day), IV, given on day1-5 repeated every 3 weeks, 3 times before surgery.
D004317, D007069
Neoadjuvant chemotherapy
Sponsors
Kurimoto Keisuke
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Median relapse-free survival time | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival Pathological assessment before and after neoadjuvant chemotherapy (Ki-67-positive ratio and FNCLCC classification) Radiological assessment before and after neoadjuvant chemotherapy (The rate of tumor shrinkage) by RESIST classification Radiological assessment SUVmax and SUVmean by PET-CT Relative dose intensity | — |
Contacts
Public ContactMasaki Sunagawa
Nagoya University Graduate School of Medicine
Outcome results
None listed