OncoMatch/Clinical Trials/NCT05057130
Neoadjuvant Combination of Doxorubicin, Cisplatin and Methotrexate in Patients Aged 24-40 Years With Primary Bone Tumors
Is NCT05057130 recruiting? Yes, currently enrolling (May 2026). This Phase 2/3 trial studies multiple treatments including Doxorubicin, Cisplatin, Methotrexate and Doxorubicin, Cisplatin for osteosarcoma.
Treatment: Doxorubicin, Cisplatin, Methotrexate · Doxorubicin, Cisplatin — Two cycles of neoadjuvant three-component chemotherapy according to the MAP prototoc: Doxorubicin 25 mg / m2 IV on days 1-3, Cisplatin 120 mg / m2 IV on day 1 against the background of hyperhydration. G-CSF support from 4 to 13 days. Methotrexate 12 g / m2 at 28 and 35 days IV with leucovorin 60 mg / m2 in the first 5 days after each administration of methotrexate. The interval between cycles is 42 days. The advantage of this regimen is to use the three-component chemotherapy regimen, which should increase the degree of tumor necrosis and increase the rate of tumor response to treatment, which will further improve the disease prognosis. Currently, the use of such treatment for adult patients (over 24 years old) is controversial. Since it is believed that the elimination of methotrexate in adult patients is more delayed than in patients under 24 years old, and can lead to serious adverse events (SAE). However, the use of modern standard methods of hemodialysis makes it possible to avoid SAE.
Check if I qualifyExtracted eligibility criteria
Cancer type
Osteosarcoma
Sarcoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Lab requirements
Blood counts
hemoglobin level more than 9 g / dL, neutrophil count more than 1.5 thousand / μl, platelet number more than 100 thousand / μl
Kidney function
Normal renal function (estimated creatinine clearance more than 60 ml / min)
Liver function
Normal liver function (AST, ALT - no more than 3 norms)
Cardiac function
Left ventricular ejection fraction > 55%
Normal renal function (estimated creatinine clearance more than 60 ml / min); Normal liver function (AST, ALT - no more than 3 norms); Left ventricular ejection fraction > 55%; Adequate marrow function (hemoglobin level more than 9 g / dL, neutrophil count more than 1.5 thousand / μl, platelet number more than 100 thousand / μl)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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