A European treatment protocol for bonesarcomain patients older than 40 years (EURO-B.O.S.S.)
- Conditions
- C40Malignant neoplasm of bone and articular cartilage of limbs
- Registration Number
- DRKS00000942
- Lead Sponsor
- Klinikum Stuttgart
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 135
1. Histologically proven diagnosis of high-grade sarcoma of bone of any site.
2. Histologic types: osteosarcoma (high-grade surface, central primary and secondary),
fibrosarcoma, malignant fibrous histiocytoma, leiomyosarcoma, dedifferentiated chondrosarcoma,
angiosarcoma.
EUROpean Bone Over 40 Sarcoma Study EURO-B.O.S.S. Version_2.0 COSS Dec 2009 13/24
3. Age: 41 - 65
4. Normal bone marrow, hepatic, cardiac and renal function
5. Absence of contraindications to the use of cisplatin, adriamycin (doxorubicin), and ifosfamide
6. Written informed consent
1. Planned chemotherapy and/or follow-up not feasible
2. Previous chemotherapy treatment, which contraindicates the use of one or more drugs, included
in the present procol
3. Previous chemotherapy treatment for the current tumor
4. White blood count < 3.0 x 109/L, and platelets < 100 x 109/L
5. Creatinine clearance < 70 ml/min
6. Left ventricular ejection fraction < 55% or fractional shortening rate of the left ventricle <28%
7. Serum transaminases and bilirubin > 2 times the normal values
8. ECOG performance status > 2
9. Chondrosarcoma or small/round cell bone sarcoma including mesenchymal chondrosarcoma and
Ewing’s family tumors.
10. Pregnancy
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method overall survival
- Secondary Outcome Measures
Name Time Method chemotherapy-related toxicity, the event free survival, and the histologic response<br>to preoperative chemotherapy.