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Clinical Trials/DRKS00000942
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

Sponsor
Klinikum Stuttgart

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