Neoadjuvant Combination of Doxorubicin, Cisplatin and Methotrexate in Patients Aged 24-40 Years With Primary Bone Tumors

Launched by BLOKHIN'S RUSSIAN CANCER RESEARCH CENTER · Sep 15, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating a combination of three chemotherapy drugs—Doxorubicin, Cisplatin, and Methotrexate—given before surgery to patients aged 24 to 40 who have been diagnosed with primary bone tumors, specifically osteosarcoma. The goal is to see if this treatment can help shrink tumors more effectively and improve overall outcomes for patients by increasing the amount of tumor tissue that is destroyed by the treatment.

To be eligible for this trial, participants must have a confirmed diagnosis of osteosarcoma, be operable (meaning surgery can be performed), and have certain health indicators like normal kidney and liver function. Those interested will receive two cycles of chemotherapy, with specific medications administered over a set schedule, followed by close monitoring for any side effects. It’s important to note that while this treatment approach is mainly used for younger patients, the trial aims to explore its safety and effectiveness in older patients, using modern techniques to manage potential side effects. If you or a loved one meet the criteria and are interested in participating, you’ll need to provide informed consent and will be supported throughout the process.

Gender

ALL

Eligibility criteria

• 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