soft tissue sarcoma
Conditions
Interventions
Sponsors
Japan Clinical Oncology Group(JCOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) A histological diagnosis of NRC-STS as malignant fibrous histiocytoma, fibrosarcoma, leiomyosarcoma, synovial sarcoma, liposarcoma, pleomorphic rhabdomyosarcoma, or undifferentiated sarcoma (WHO classification) using open biopsy specimen 2) FNCLCC histological grading system: grade 2 or 3 in the open biopsy specimen 3) 10 or more unstained tumor tissue slides are available 4) AJCC stage: stage III (T2bN0M0) 5) localized tumor in the extremities 6) measurable lesion on MRI axial section 7) operable tumor 8) no history of soft tissue sarcoma 9) no history of treatment for NRC-STS, chemotherapy nor radiation therapy for any cancer 10) age >20 and <65 11) an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 12) sufficient organ function within 14 days of entry 13) no blood transfusion within 14 days of entry 14) written informed consent
Exclusion criteria
Exclusion criteria: 1) Poorly controlled diabetes mellitus 2) poorly controlled hypertension 3) history of myocardial infarction or angina 4) cardiac pacemaker 5) severe urinary dysfunction 6) infectious disease which requires treatment 7) mental disease or mental symptoms which would affect the patient's decision to participate 8) women in pregnant, possibly pregnant or breast feeding 9) active double cancer 10) continuous systemic medication of steroids
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| 2-year progression free survival, time to progression, overall survival, adverse effect, post-operative morbidity | — |
Countries
Japan
Contacts
Public ContactKazuhiro Tanaka, MD, PhD
JCOG0304 Coordinating Office Department of Orthopaedic Surgery, Kyushu University Hospital
Outcome results
None listed