European Study in Bone Sarcoma Patients Over 40 Years

Completed

• Conditions: Osteosarcoma; Spindle Cell Sarcoma of Bone
• Interventions: Drug: Doxorubicin+cisplatin+ifosfamide; Drug: Doxorubicin+cisplatin+ifosfamide+methotrexate

• Registration Number: NCT02986503
• Lead Sponsor: Italian Sarcoma Group

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.

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).

Study Timeline

• Study Start: 2002-01
• Primary Completion: 2015-12
• Study Completion: 2016-11
• Study First Submitted: 2016-11-25
• Status Verified: 2016-12
• Study First Submitted QC: 2016-12-05
• Last Update Submitted: 2016-12-05
• Study First Posted: 2016-12-08
• Last Update Posted: 2016-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chemotherapy for Good responder	Doxorubicin+cisplatin+ifosfamide	Doxorubicin + cisplatin + ifosfamide Pre-operative and post-operative chemotherapy for patients with good responder high grade osteosarcoma
Chemotherapy for Poor responder	Doxorubicin+cisplatin+ifosfamide+methotrexate	Doxorubicin+cisplatin+ifosfamide+methotrexate Pre-operative and post-operative chemotherapy for patients with poor responder high grade osteosarcoma

Primary Outcome Measures

Name	Time	Method
Event-free survival	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.	Survival without any events related to disease (e.g: progression, relapse or osteosarcoma related death)

Secondary Outcome Measures

Name	Time	Method
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	Survival without disease
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	Survival without progression of disease
Chemotherapy toxicity	Every 3 weeks	Number and grade of adverse events related to the study treatments
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	Survival without metastasis
Overall survival	from the date of randomization until the end of the study, assessed every 3 months, up to 168 month	Global patients survival evaluation after treatment

Trial Locations

Locations (3)

Cooperative Osteosarcoma Study Group; 🇩🇪 Stuttgart, Germany

Istituti Ortopedici Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors; 🇮🇹 Bologna, Italy

Scandinavian Sarcoma Group; 🇸🇪 Lund, Sweden