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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02986503
Other study ID # EURO-B.O.S.S
Secondary ID
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


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
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