soft tissue sarcoma
Conditions
Interventions
A: Three courses of preoperative chemotherapy with adriamycin(30mg/m2/day, day 1-2) and ifosphamide(2g/m2/day, day 1-5) every three weeks followed by surgical resection and two courses of postperative
Sponsors
Japan Clinical Oncology Group (JCOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Grade 2 or 3 (FNCLCC histological grading system) non-round cell soft-tissue sarcoma (NRC-STS) with histology of undifferentiated pleomorphic sarcoma, fibrosarcoma, leiomyosarcoma, synovial sarcoma, liposarcoma, pleomorphic rhabdomyosarcoma, angiosarcoma, malignant peripheral nerve sheth tumor or undifferentiated sarcoma (WHO classification) using open biopsy specimen 2) Primary tumor or first local recurrent tumor 3) 10 or more unstained tumor tissue slides are available 4) UJCC/AJCC TNM (7th edition): T2bN0M0 or any TN1M0 (in case of primary tumor) 5) No distant metastases (in case of first local recurrent tumor) 6) Tumor in the extremities or trunk 7) Having measurable lesion on MRI axial section 8) Resectable with appropriate margins 9) Age >= 20 and =< 70 10) An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 11) No history of chemotherapy nor radiation therapy for any cancer including NRC-STS 12) Sufficient organ function 13) No abnormal ECG findings 14) Not diagnosed as interstitial pneumonia, pulmonary emphysema nor pulmonary fibrosis with chest CT finding 15) Written informed consent.
Exclusion criteria
Exclusion criteria: 1) Synchronous or metachronous (within 5 years) malignancies except for carcinoma in situ or intramucosal tumors curatively treated with local therapy 2) Active infection requiring systemic therapy 3) Body temperature >= 38 degrees Celsius 4) Women in pregnant, possibly pregnant or breast feeding 5) Psychiatric disease 6) Patients requiring systemic steroid medication 7) Unstable angina within 3 weeks, or with a history of myocardial infarction 8) Poorly controlled hypertension 9) Poorly controlled diabetes mellitus or routine administration of insulin 10) Positive HBs antigen
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PhaseII: Proportion of completion of preoperative chemotherapy without progression disease. Phase III: Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| PhaseII/III: Progression-free survival. Response rate of preoperative chemotherapy, Pathological response rate of preoperative chemotherapy, Proportion of preservation of diseased limb(extremities),Disease control rate (extremities and trunks), Adverse events, Serious adverse events, Respiratory-related adverse events and Postoperative complication. | — |
Countries
Japan
Contacts
Public ContactKazuhiro Tanaka, MD, PhD
JCOG1306 Coordinating Office Department of Orthopaedic Surgery, Oita University Hospital
Outcome results
None listed