High-grade bone and soft tissue tumor
Conditions
Interventions
Caffeine combined chemotherapy in which cisplatin over 4 hours followed by caffeine over 24 hours on days 1-3, to be repeaed every 3 weeks
Sponsors
Group for "Caffeine combined chemotherapy in patients with high-grade bone and soft tissue tumor"
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. bone tumor (osteosarcoma, malignant fibrous histiocytoma), soft tissue tumor (non-round cell soft tissue tumor: malignant fibrous histiocytoma, fibrosarcoma, leiomyosarcoma, synovial sarcoma, liposarcoma, pleomorphic rhabdomyosarcoma, undifferentiated sarcoma) 2. Grade 2-3 high grade tumor judged by FNCLCC(French Federation of Cancer Center) system 3. extremity, trunk, retroperitoneum 4. calculatable tumor size by MRI 5. resectable 6. no history of malignant bone and soft tissue tumor 7. no prior chemotherapy or radiation for malignant tumor 8. 0-1 in ECOG PS confirming the following laboratory results (1) WBC>=3000/mm3, Hb>=8g/dL, P1t>=100000/mm3 (2) liver renzyme: serum T-bil<=1.5mg/dL, GOT, GPT<=2 X normal value (3) serum creatinine<=1.5 mg/dL, Ccr>=60 mL/min (4) normal findings of ECG and cardiac ultrasound (5) blood gas analysis: PaO2>=70 mmHg, (PaCO2<=50 Torr) 9. no evidence of psycosis, sever diabetes mellitus, uncontrolled hypertension 10. written informed consent from patients or legal guardian (20 years and under)
Exclusion criteria
Exclusion criteria: 1.sever drug allergy 2.uncontrolled diabetes mellitus 3.uncontrolled hypertension 4.women during pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The response rate of preoperative caffeine combined chemotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| 2-year progression free survival, event-free survival, overall survival, incidence of adverse event | — |
Countries
Japan
Contacts
Public ContactToshiharu Shirai
Coordinate Office Department of orthopaedic surgery, Graduate school of medical science, Kanazawa Univesity
Outcome results
None listed