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Italian Sarcoma Group: non-metastatic OsteoSarcoma 1

Italian Sarcoma Group: non-metastatic OsteoSarcoma 1

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN21335128
Enrollment
246
Registered
2006-03-01
Start date
2001-04-02
Completion date
Unknown
Last updated
2021-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteosarcoma Cancer Bone cancer

Interventions

Patients are randomised to receive a treatment with methotrexate, doxorubicin, cisplatinum and ifosfamide since the primary treatment or to receive a primary treatment with methotrexate, doxorubicin a

Sponsors

Orthopaedic Institute Rizzoli (Istituti Ortopedici Rizzoli) (Italy)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with typical radiographic and histological features of primary, high-grade central osteosarcoma 2. Tumour located in the extremity 3. No previous history of cancer and no prior treatments 4. Aged under 40 5. No co-existing disease contraindicating chemotherapy 6. No evidence of metastases at diagnosis 7. Informed consent

Exclusion criteria

Exclusion criteria: 1. Metastatic osteosarcoma 2. Previous history of cancer 3. Co-existing disease contraindicating chemotherapy 4. No informed consent

Design outcomes

Primary

MeasureTime frame
Clinical efficacy in terms of event free survival, disease free survival and overall survival.

Secondary

MeasureTime frame
To compare the toxicity of the two regiments.

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026