Phase
Condition
Neoplasms
Sarcoma
Osteosarcoma
Treatment
Doxorubicin, Cisplatin
Doxorubicin, Cisplatin, Methotrexate
Clinical Study ID
Ages 24-40 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: Histologically confirmed diagnosis of primary bone tumor (osteosarcoma) Age from 24 to 40 years Operable process, possibility of performing resection R0-R1 ECOG performance score 0 or 1 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) Signed informed consent
Exclusion
Exclusion Criteria: Children, women during pregnancy, childbirth, women during breastfeeding Persons with mental disorders The presence of an active viral infection with HIV, viral hepatitis B and C Inoperable tumor Morphologically confirmed diagnosis of GIST, Kaposi's sarcoma, alveolar or clear cellsarcoma, chondrosarcoma, chordoma, giant cell tumor, paraosal osteosarcoma, Ewing's sarcoma / PNET, rhabdomyosarcoma, G1 osteosarcoma The presence of a second malignant neoplasm within the last 5 years before enrollment,other than cured basal cell or squamous cell carcinoma or cervical cancer in situ, prostatecancer Clinically significant cardiovascular or cerebrovascular diseases within the last 6 months (acute myocardial infarction, unstable angina pectoris, significant ventriculararrhythmias, severe heart failure (NYHA class IV), stroke or uncontrolled arterialhypertension) Renal failure (serum creatinine level more than 150 μmol / L), except for cases caused bylymphoid infiltration of the kidneys, and tumor disintegration syndrome Hepatic failure (except for cases caused by leukemic / lymphoid organ infiltration), acutehepatitis (serum bilirubin level more than 2 norms, ALT and AST activity more than 4 norms,prothrombin index less than 50%) Decompensated diabetes mellitus (blood serum glucose above 15 mmol / L) Sepsis (septicopyemic foci, hemodynamic instability; ineffective antimicrobial therapy) oracute infectious diseases Brain metastases Life-threatening conditions (bleeding, tumor decay, etc.) Hypersensitivity to the active substance of the investigational drugs or any of theauxiliary components or their intolerance Surgical interventions less than 21 days before starting therapy
Study Design
Study Description
Connect with a study center
Federal State Budgetary Institution "N.N. Blokhin National Medical Research Center of Oncology" оf the Ministry of Health of the Russian Federation
Moscow, 115478
Russian FederationActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.