Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:43 PM
Ignite Modification Date:
2025-12-24 @ 7:43 PM
NCT ID:
NCT02986503
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
41 Years
Maximum Age:
65 Years
Study:
NCT02986503
Study Brief:
Protocol Section:
NCT02986503