Chemotherapy consists of Adriamycin and Ifosfamide for the patients with high grade primary bone sarcoma except for Ewing sarcoma over 41, Phase II trial
Phase 2
- Conditions
- patients with high grade primary bone sarcoma except for Ewing sarcoma over 41
- Registration Number
- JPRN-UMIN000015982
- Lead Sponsor
- Japanese Musculoskeletal Oncology Group; JMOG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 35
Inclusion Criteria
Not provided
Exclusion Criteria
1)Severe comorbid illness 2)Active infection 3)Synchronous or metachronous (within 5 years) malignancies 4)History of chemotherapy using ADR and/or IFO 5)Poorly renal or bladder function 6)Severe myelosuppression 7)Abnormal heart function 8)Patients having a pacemaker 9)Patients requiring pentostatin 10)Women in pregnant, possibly pregnant or breast feeding 11)Patients requiring systemic steroid medication 12)Psychiatric disease 13)Positive HBs antigen, HBs antibody, or HBc antibody
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 3-year progression- free survival
- Secondary Outcome Measures
Name Time Method Proportion of completion of preoperative chemotherapy without progression disease, 5-year progression- free survival, progression- free survival, overall survival, disease progression rate, preoperative progression rate, adverse event, postoperative complication rate, the ratio of the patients who were performed limb sparing surgery, function of postoperative limb