Trial document




drksid header

  DRKS00000942

Trial Description

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Title

A European treatment protocol for bonesarcoma
in patients older than 40 years (EURO-B.O.S.S.)

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Trial Acronym

Euro-B.O.S.S.

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Bone sarcomas frequently appear with young people, there are only limited experience in patients aged more than 40 years. The aim of EURO- B.O.S.S. is the verification of the prognosis in patients with bone sarcoma aged 41-65 years and to achieve a high cure rate. This will be achieved by the use of a standard therapy of approved drugs.

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Brief Summary in Scientific Language

The trial EURO-B.O.S.S. is a multicentre prospective study for patients older than 40 years with highly malignant spindle cell sarcoma of bone. Because of the low incidence of bone sarcomas,multiinstitutional collaborations are essential to address important questions concerning diagnosis and treatment. The participating intergroups cover a population of approximately 200 million people and together these organizations claim to provide an adequate patient volume to explore the aims of the current study.

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Organizational Data

  •   DRKS00000942
  •   2015/03/19
  •   2005/03/03
  •   yes
  •   Approved
  •   4 I Bielack, Ethik-Kommission der Ärztekammer Westfalen-Lippe und der med. Fakultät der Westfälischen Wilhelms-Universität Münster
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Secondary IDs

  •   UKF000236  (Register klinischer Studien des Universitätsklinikums Freiburg)
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Health Condition or Problem studied

  •   C40 -  Malignant neoplasm of bone and articular cartilage of limbs
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Interventions/Observational Groups

  •   Standard therapy of approved drugs in osteosarcoma patients aged more than 40 years.
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   II-III
  •   No
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Primary Outcome

overall survival

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Secondary Outcome

chemotherapy-related toxicity, the event free survival, and the histologic response
to preoperative chemotherapy.

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Countries of Recruitment

  •   Germany
  •   Sweden
  •   Italy
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2009/11/24
  •   135
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   40   Years
  •   65   Years
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Additional 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

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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

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinikum Stuttgart
    • Mr.  Prof. Dr.  Stefan  Bielack 
    • Postfach 103652
    • 70031  Stuttgart
    • Germany
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    • Klinik Stuttgart
    • Mr.  Prof. Dr.  Stefan  Bielack 
    • Postfach 103652
    • 70031  Stuttgart
    • Germany
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    end of 1:1-Block address contact scientific-contact
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    • Klinik Stuttgart
    • Mr.  Prof. Dr.  Stefan  Bielack 
    • Postfach 103652
    • 70031  Stuttgart
    • Germany
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Sources of Monetary or Material Support

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    • Klinik Stuttgart
    • Mr.  Prof. Dr.  Stefan  Bielack 
    • Postfach 103652
    • 70031  Stuttgart
    • Germany
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    •   +49 711 992-2461
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    •   [---]*
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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