Sarcoma Clinical Trial
Official title:
Neoadjuvant Three-component Chemotherapy Based on a Combination of Doxorubicin, Cisplatin and Methotrexate in Patients Aged 24-40 Years With Primary Bone Tumors to Increase the Response Rate Compared With Two-component Chemotherapy
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 2024 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 24 Years to 40 Years |
Eligibility | 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 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 cell sarcoma, 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, prostate cancer Clinically significant cardiovascular or cerebrovascular diseases within the last 6 months (acute myocardial infarction, unstable angina pectoris, significant ventricular arrhythmias, severe heart failure (NYHA class IV), stroke or uncontrolled arterial hypertension) Renal failure (serum creatinine level more than 150 µmol / L), except for cases caused by lymphoid infiltration of the kidneys, and tumor disintegration syndrome Hepatic failure (except for cases caused by leukemic / lymphoid organ infiltration), acute hepatitis (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) or acute infectious diseases Brain metastases Life-threatening conditions (bleeding, tumor decay, etc.) Hypersensitivity to the active substance of the investigational drugs or any of the auxiliary components or their intolerance Surgical interventions less than 21 days before starting therapy |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Federal State Budgetary Institution "N.N. Blokhin National Medical Research Center of Oncology" ?f the Ministry of Health of the Russian Federation | Moscow |
Lead Sponsor | Collaborator |
---|---|
Blokhin's Russian Cancer Research Center |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall Response Rate | Proportion of patients who have a partial or complete response to therapy | 6 months | |
Secondary | Comparison of tumor necrosis | Proportion of tumor necrosis after chemotherapy | 6 months | |
Secondary | Comparison of safety assessment | Adverse Event Assessment and Serious Adverse Event Assessment according to CTCAE 5.0 | 6 months |
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