JPRN-jRCTs041230007
Recruiting
Phase 2
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 enrollmentApril 14, 2023
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Kurimoto Keisuke
- Enrollment
- 23
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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
Outcomes
Primary Outcomes
Not specified
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