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

Who is this study for? Patients with Sarcoma
What treatments are being studied? Doxorubicin, Cisplatin
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 24
Maximum Age: 40
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Russian Federation
Federal State Budgetary Institution N.N. Blokhin National Medical Research Center of Oncology оf the Ministry of Health of the Russian Federation
RECRUITING
Moscow
Contact Information
Primary
Anastasia Tararykova
anastasiatararykova@gmail.com
+79175274287
Time Frame
Start Date: 2022-01-10
Estimated Completion Date: 2024-12
Participants
Target number of participants: 50
Treatments
Experimental: Three-component chemotherapy
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
Active_comparator: Two-component chemotherapy
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. The interval between cycles is 28 days
Sponsors
Leads: Blokhin's Russian Cancer Research Center

This content was sourced from clinicaltrials.gov

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