Combination chemotherapy for bone tumors in young adults
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
This study is testing a new combination of chemotherapy drugs for young adults with bone tumors to see if it helps shrink the tumors and improve their chances of recovery.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 24 Years to 40 Years |
| Sex | All |
| Sponsor | Blokhin's Russian Cancer Research Center Academic / other |
| Drugs / interventions | chemotherapy, Methotrexate, Doxorubicin |
| Locations | 1 site (Moscow) |
| Trial ID | NCT05057130 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of a neoadjuvant chemotherapy regimen combining Doxorubicin, Cisplatin, and Methotrexate in patients aged 24 to 40 years with primary bone tumors, specifically osteosarcoma. Participants will receive two cycles of this three-component chemotherapy, with careful monitoring of drug administration and potential side effects. The study aims to improve tumor response rates and reduce the likelihood of recurrence by optimizing the use of Methotrexate, which has shown promise in previous studies despite concerns regarding its safety in older patients. The trial will assess the impact of this regimen on treatment outcomes and overall disease prognosis.
Who should consider this trial
Good fit: Ideal candidates are adults aged 24 to 40 with a histologically confirmed diagnosis of operable primary bone tumors.
Not a fit: Patients with inoperable tumors or those with specific types of sarcomas other than osteosarcoma may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the prognosis and response rates for young adults with primary bone tumors.
How similar studies have performed: Previous studies have shown promising results with similar chemotherapy regimens, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Moscow
- Federal State Budgetary Institution "N.N. Blokhin National Medical Research Center of Oncology" оf the Ministry of Health of the Russian Federation — Moscow, Russian Federation (Recruiting)
Study contacts
- Principal investigator: Beniamin Bokhyan, PhD — N.N. Blokhin NMRCO
- Study coordinator: Anastasia Tararykova
- Email: anastasiatararykova@gmail.com
- Phone: +79175274287
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.