NCT02986503

European Study in Bone Sarcoma Patients Over 40 Years

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Italian Sarcoma Group · Network
• Sex: All
• Age: 41 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Spindle Cell Sarcoma of Bone
• Osteosarcoma

Interventions

Type	Name	Description
DRUG	Doxorubicin+cisplatin+ifosfamide	Chemotherapy for Good responder high grade osteosarcoma
DRUG	Doxorubicin+cisplatin+ifosfamide+methotrexate	Chemotherapy for Poor responder high grade osteosarcoma

Timeline

• Start date: 2002-01-01
• Primary completion: 2015-12-01
• Completion: 2016-11-01
• First posted: 2016-12-08
• Last updated: 2016-12-08

Locations

3 sites across 3 countries: Germany, Italy, Sweden