European Study in Bone Sarcoma Patients Over 40 Years

NCT02986503 | Completed

• 1 other identifier: EURO-B.O.S.S
• Study Type: observational
• Target: 100
• Locations: 3 countries
• Sites: 3

Brief Summary

The study is a first step of a process to establish the standard chemotherapy treatment with the aim to improve outcome for patients with these rare tumours. For this reason the study will be non-controlled clinical trial. In this regard, the study aims to determine the feasibility of intensive chemotherapy in this age group, and/or separate efficacy analyses according to the different histologic categories and whether the number of patients recruited by the co-operating groups permits future randomised studies.

Conditions

Spindle Cell Sarcoma of Bone; Osteosarcoma

Outcome Measures

Primary Outcomes (1)

• Event-free survival

  Survival without any events related to disease (e.g: progression, relapse or osteosarcoma related death)

  from the date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 168 months.

Secondary Outcomes (5)

• Progression-free survival

  from the date of randomization until the date of first documented progression of disease, whichever came first, assessed every 6 months, up to 168 months

• Disease-free survival

  from the date of randomization until the date of first documented progression of disease, whichever came first, assessed every 6 months, up to 168 months

• Metastasis-free survival

  from the date of randomization until the date of first documented progression in term of metastasis, whichever came first, assessed every 3 months, up to 168 months

• Overall survival

  from the date of randomization until the end of the study, assessed every 3 months, up to 168 month

• Chemotherapy toxicity

  Every 3 weeks

Study Arms (2)

Chemotherapy for Good responder

Doxorubicin + cisplatin + ifosfamide Pre-operative and post-operative chemotherapy for patients with good responder high grade osteosarcoma

Drug: Doxorubicin+cisplatin+ifosfamide

Chemotherapy for Poor responder

Doxorubicin+cisplatin+ifosfamide+methotrexate Pre-operative and post-operative chemotherapy for patients with poor responder high grade osteosarcoma

Drug: Doxorubicin+cisplatin+ifosfamide+methotrexate

Interventions

Doxorubicin+cisplatin+ifosfamide DRUG

Chemotherapy for Good responder high grade osteosarcoma

Also known as: Doxorubicin,cisplatin,ifosfamide

Chemotherapy for Good responder

Doxorubicin+cisplatin+ifosfamide+methotrexate DRUG

Chemotherapy for Poor responder high grade osteosarcoma

Also known as: Doxorubicin,cisplatin,ifosfamide,methotrexate

Chemotherapy for Poor responder

Eligibility Criteria

• Age: 41 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients older than 40 years with highly malignant spindle cell sarcoma of bone

You may qualify if:

• Histologically proven diagnosis of high-grade sarcoma of bone of any site.
• Histologic types: osteosarcoma (high-grade surface, central primary and secondary), fibrosarcoma, malignant fibrous histiocytoma, leiomyosarcoma, dedifferentiated chondrosarcoma, angiosarcoma.
• Age: 41 - 65
• Normal bone marrow, hepatic, cardiac and renal function
• Absence of contraindications to the use of cisplatin, adriamycin, and ifosfamide
• Written informed consent

You may not qualify if:

• Planned chemotherapy and/or follow-up not feasible
• Previous chemotherapy treatment, which contraindicates the use of one or more drugs, included in the present protocol
• Previous chemotherapy treatment for the current tumor
• White blood count \< 3.0 x 109/L, and platelets \< 100 x 109/L
• Creatinine clearance \< 70 ml/min
• Left ventricular ejection fraction \< 55% or fractional shortening rate of the left ventricle \<28%
• Serum transaminases and bilirubin \> 2 times the normal values
• ECOG performance status \> 2
• Chondrosarcoma or small/round cell bone sarcoma including mesenchymal chondrosarcoma and Ewing's family tumors.

Sponsors & Collaborators

• Italian Sarcoma Group: lead
• Scandinavian Sarcoma Group: collaborator
• Cooperative Osteosarcoma Study Group: collaborator

Study Sites (3)

Cooperative Osteosarcoma Study Group

Stuttgart, D-70176, Germany

Location

Istituti Ortopedici Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors

Bologna, Bologna, 40136, Italy

Location

Scandinavian Sarcoma Group

Lund, SE-221 85, Sweden

Location

Related Links

• Euroboss I - A European treatment protocol for bone sarcoma in patients older than 40 years

MeSH Terms

Conditions

Osteosarcoma

Interventions

Doxorubicin

Condition Hierarchy (Ancestors)

Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Stefano Ferrari, MD

  Italian Sarcoma Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2016
• First Posted: December 8, 2016
• Study Start: January 1, 2002
• Primary Completion: December 1, 2015
• Study Completion: November 1, 2016
• Last Updated: December 8, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will share

Locations

DE (1); SE (1); IT (1)