JCOG2102: Randomized phase III trial of Neo-adjuvant and adjuvant chemotherapy vs Adjuvant Chemotherapy alone for LocalizEd Soft tissue Sarcoma
- Conditions
- Resectable high grade non-round cell soft tissue sarcoma
- Registration Number
- JPRN-jRCTs031220446
- Lead Sponsor
- TANAKA Kazuhiro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 224
(1) Grade 2 or 3 (FNCLCC histological grading system) non-round cell soft-tissue sarcoma with histology of undifferentiated sarcoma (pleomorphic, spindle cell), adult fibrosarcoma, myxofibrosarcoma, leiomyosarcoma, synovial sarcoma, liposarcoma (dedifferentiated, myxoid, pleomorphic), pleomorphic rhabdomyosarcoma, malignant peripheral nerve sheath tumor, angiosarcoma (WHO classification 2020) using open biopsy specimen
(2) 10 or more unstained tumor tissue slides are available
(3) Primary tumor
(4) Tumor in the extremities or trunk
(5) T2-4N0M0 (UICC/AJCC, 8th edition) and deeply seated (localized deeper than the investing fascia, invades the investing fascia, or penetrates the investing fascia) according to the latest imaging studies
(6) Having measurable lesion on MRI axial section
(7) resectable with marginal or wide margin
(8) Age between 16 and 70 years
(9) ECOG Performance status (PS) of 0 or 1
(10) No history of chemotherapy nor radiation therapy for any cancer including NRC-STS
(11) All of the following are met for the most recent laboratory findings within 14 days prior to enrollment:
(i) Neutrophil count >= 1,500/mm3
(ii) Hemoglobin >= 8.0 g/dL (No blood transfusion within 14 days prior to the test used for registration)
(iii) Platelet count >=100,000/mm3
(iv) Total bilirubin <=1.5 mg/dL
(v) AST<=100 U/L
(vi) ALT<=100 U/L
(vii) Serum creatinine<=1.5 mg/dL
(viii) Creatinine clearance >=60 mL/min
(12) The latest ECG within 35 days prior to enrollment shows normal or no changes requiring treatment
(13) Written informed consent
(1) Synchronous or metachronous (within 5 years) malignancies except cancer with 5-year relative survival rate of 95% or more
(2) Active infection requiring systemic therapy
(3) Body temperature >= 38 degrees Celsius
(4) Women (possibly) in pregnancy, within 28 days postpartum, or breast feeding. Men who wish to get his partner pregnant
(5) Patients with psychiatric disorders or psychiatric symptoms
(6) Patients requiring systemic steroid medication
(7) Poorly controlled diabetes mellitus or routine administration of insulin
(8) Poorly controlled hypertension
(9) Unstable angina within 3 weeks, or with a history of myocardial infarction
(10) Poorly controlled valvular disease, dilated cardiomyopathy, or hypertrophic cardiomyopathy
(11) Positive HBs antigen
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method