DRKS00000942CompletedNot Applicable
A European treatment protocol for bonesarcomain patients older than 40 years (EURO-B.O.S.S.) - Euro-B.O.S.S.
Klinikum Stuttgart0 sites135 target enrollmentStarted: March 19, 2015Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 135
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 40 Years to 65 Years (—)
- Sex
- All
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Investigators
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