European Study in Bone Sarcoma Patients Over 40 Years

Osteosarcoma Clinical Trial

— EUROBOSS  

Official title:

A European Treatment Protocol for Bone-sarcoma in Patients Older Than 40 Years

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02986503
• Other study ID #: EURO-B.O.S.S
• Status: Completed
• Phase: N/A
• First received: November 25, 2016
• Last updated: December 5, 2016
• Start date: January 2002
• Est. completion date: November 2016

Study information

• Verified date: December 2016
• Source: Italian Sarcoma Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Description:

Wide surgical removal of the tumor with the addition of a systemic treatment based on the antineoplastic drugs active against osteosarcoma (Adriamycin, Cisplatin, Ifosfamide, Methotrexate). The use of radiation therapy will be given to patients with unresectable tumors. It is recommended in patients who underwent inadequate surgical removal of the tumor. The addition of radiation therapy can not compensate for an adequate surgical treatment.

All the patients eligible for the study will receive the planned systemic treatment. Depending on clinical features, and feasibility of adequate surgical removal of the tumor, patients may receive primary chemotherapy followed by a postoperative chemotherapy treatment or only an adjuvant chemotherapy. In case of immediate surgery, patients will receive an adjuvant treatment with the 3-drug regimen (Cisplatin-Adriamycin-Ifosfamide).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 41 Years to 65 Years

Eligibility

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.

3. Age: 41 - 65

4. Normal bone marrow, hepatic, cardiac and renal function

5. Absence of contraindications to the use of cisplatin, adriamycin, 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 protocol

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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Osteosarcoma
• Sarcoma
• Spindle Cell Sarcoma of Bone

Intervention

Drug:
• Doxorubicin+cisplatin+ifosfamide
Chemotherapy for Good responder high grade osteosarcoma
• Doxorubicin+cisplatin+ifosfamide+methotrexate
Chemotherapy for Poor responder high grade osteosarcoma

Locations

Country	Name	City	State
Germany	Cooperative Osteosarcoma Study Group	Stuttgart
Italy	Istituti Ortopedici Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors	Bologna
Sweden	Scandinavian Sarcoma Group	Lund

Sponsors (3)

Lead Sponsor	Collaborator
Italian Sarcoma Group	Cooperative Osteosarcoma Study Group, Scandinavian Sarcoma Group

Countries where clinical trial is conducted

Germany,  Italy,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	Progression-free survival	Survival without progression of disease	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	No
Secondary	Disease-free survival	Survival without disease	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	No
Secondary	Metastasis-free survival	Survival without metastasis	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	No
Secondary	Overall survival	Global patients survival evaluation after treatment	from the date of randomization until the end of the study, assessed every 3 months, up to 168 month	No
Secondary	Chemotherapy toxicity	Number and grade of adverse events related to the study treatments	Every 3 weeks	Yes

External Links

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