RecruitingPhase 2Phase 3NCT05057130

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

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


Sponsor

Blokhin's Russian Cancer Research Center

Enrollment

50 participants

Start Date

Jan 10, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 24 YearsMax Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates a chemotherapy combination — doxorubicin, cisplatin, and methotrexate — given before surgery to treat primary bone cancer (osteosarcoma) in young adults aged 24–40. The goal is to shrink the tumor before removing it surgically. **You may be eligible if...** - You are aged 24–40 with a confirmed diagnosis of osteosarcoma (primary bone tumor) - Your tumor is operable (can be surgically removed) - You have good kidney, liver, and heart function - You have adequate blood counts **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have HIV, hepatitis B, or hepatitis C - Your tumor is inoperable - You have a different type of bone/soft tissue cancer (e.g., Ewing's sarcoma, chondrosarcoma, chordoma) - You have had another cancer in the last 5 years - You have a mental health condition that prevents you from participating Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDoxorubicin, Cisplatin, Methotrexate

IV

DRUGDoxorubicin, Cisplatin

IV


Locations(1)

Federal State Budgetary Institution "N.N. Blokhin National Medical Research Center of Oncology" оf the Ministry of Health of the Russian Federation

Moscow, Russia

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NCT05057130


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