neoadjuvant AI therapy for retroperitoneal de-differentiated liposarcoma

JRCT ID: jRCTs041230007

Registered date:14/04/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Retroperitoneal de-differentiated liposarcoma
• Date of first enrollment: 14/04/2023
• Target sample size: 23
• Study type: Interventional
• Intervention(s): 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.

Outcome(s)

• Primary Outcome: Median relapse-free survival time

Secondary Outcome

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

Key inclusion & exclusion criteria

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

Include 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

Exclude 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

Related Information

• Primary Sponsor: Kurimoto Keisuke