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OsteosarcomaPhase 2/3NCT05057130

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

A Phase 2/3 study testing Doxorubicin, Cisplatin, Methotrexate and Doxorubicin, Cisplatin in people with Osteosarcoma and Neoplasms, Connective Tissue, run by Blokhin's Russian Cancer Research Center at 1 site in Russia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 24 to 40 years
What is being tested?
Doxorubicin, Cisplatin, Methotrexate and Doxorubicin, Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteRussia
Study dates
10 Jan 2022to Dec 2024
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 24 to 40 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

Anastasia Tararykova contact

+79175274287

anastasiatararykova@gmail.com

Russia1 site, 1 recruiting

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

    Moscow, 115478

    Anastasia Tararykova, 89175274287, anastasiatararykova@gmail.com

    Anastasia Tararykova

    Recruiting

Other trials in Russia

About this study

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.

Read the detailed description

The role of methotrexate in neoadjuvant chemotherapy for bone tumors is a topic for debate. However, the benefits of methotrexate have been confirmed in at least one phase II study showing better results with high doses of methotrexate in the context of triple chemotherapy. Moreover, many studies have shown a correlation between peak serum methotrexate levels, tumor response to chemotherapy, and treatment outcome. Thus, it is possible that the negative results of the effectiveness of methotrexate have been compromised due to the administration of insufficient doses or incorrect administration of the drug. The optimal regimen of methotrexate administration has not been established. However, the control group in the EURAMOS-1 study of the American Osteosarcoma Research Group (AOST) is considered as the standard. The main practical problem with the use of triple chemotherapy in a group of patients aged 24 and older is that the slow clearance of methotrexate can delay the administration of the next cycle of doxorubicin-cisplatin, thereby reducing the dose intensity and adversely affecting the outcome. Currently, there are both isolated clinical cases and observations of a small number of included patients. The use of three-component neoadjuvant chemotherapy for primary bone tumors will improve the rate of response to treatment, reduce the frequency of recurenses and disease progression.

Being tested
Doxorubicin, Cisplatin, Methotrexate, Doxorubicin, Cisplatin
Keywords
Bone sarcoma
Medical subject headings
Osteosarcoma, Neoplasms, Connective Tissue, Neoplasms, Connective and Soft Tissue, Sarcoma, Bone Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Doxorubicin, Cisplatin, MethotrexateDrug

    Also called MAP

    IV

  • Doxorubicin, CisplatinDrug

    Also called AP

    IV

Study groups in NCT05057130
Study groupRoleWhat they receive
Three-component chemotherapyExperimentalDoxorubicin 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
Receives: Drug: Doxorubicin, Cisplatin, Methotrexate
Two-component chemotherapyActive comparatorDoxorubicin 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
Receives: Drug: Doxorubicin, Cisplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate

    Proportion of patients who have a partial or complete response to therapy

    Measured: 6 months

Secondary outcomes (2)

  1. Comparison of tumor necrosis

    Proportion of tumor necrosis after chemotherapy

    Measured: 6 months

  2. Comparison of safety assessment

    Adverse Event Assessment and Serious Adverse Event Assessment according to CTCAE 5.0

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2021
  2. Study start10 Jan 2022
  3. Primary completionDec 2024 (estimated)
  4. Study completionDec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05057130
Sponsor's protocol ID
AMAP2021-7-2
Status last verified
Mar 2024
First submitted
7 Sep 2021
Last updated
1 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Doxorubicin, Cisplatin, Methotrexate and Doxorubicin, Cisplatin in people with Osteosarcoma and Neoplasms, Connective Tissue, run by Blokhin's Russian Cancer Research Center at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Anastasia Tararykova (+79175274287, anastasiatararykova@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05057130.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2024.

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