European Study in Bone Sarcoma Patients Over 40 Years — EUROBOSS  

Osteosarcoma Clinical Trial

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

Status Completed

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.

Clinical Trial 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). ;

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Osteosarcoma
• Sarcoma
• Spindle Cell Sarcoma of Bone

• NCT number: NCT02986503
• Study type: Observational
• Source: Italian Sarcoma Group
• Status: Completed
• Phase: N/A
• Start date: January 2002
• Completion date: November 2016