Clinical trial · Observational
European Study in Bone Sarcoma Patients Over 40 Years
A European Treatment Protocol for Bone-sarcoma in Patients Older Than 40 Years
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Osteosarcoma | Osteosarcoma | ONTOLOGY_EXACT | 0.90 |
| Spindle Cell Sarcoma of Bone | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Doxorubicin+cisplatin+ifosfamide | Drug | — | UNRESOLVED |
| Doxorubicin+cisplatin+ifosfamide+methotrexate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Chemotherapy for Good responder
- description
- Doxorubicin + cisplatin + ifosfamide Pre-operative and post-operative chemotherapy for patients with good responder high grade osteosarcoma
- interventionNames
- Drug: Doxorubicin+cisplatin+ifosfamide
- label
- Chemotherapy for Poor responder
- description
- Doxorubicin+cisplatin+ifosfamide+methotrexate Pre-operative and post-operative chemotherapy for patients with poor responder high grade osteosarcoma
- interventionNames
- Drug: Doxorubicin+cisplatin+ifosfamide+methotrexate
Primary outcomes (1)
- measure
- Event-free survival
- timeFrame
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 41 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available