Phase II, multicenter, randomized, open-label study with MAP +/- denosumab regimen for the treatment of patients with metastatic osteosarcoma

Phase II, multicenter, randomized, open-label study with MAP +/- denosumab regimen for the treatment of patients with metastatic osteosarcoma - AIEOP-ISG OsM+

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-002366-41-IT

Enrollment

112

Registered

2021-10-18

Start date

2021-09-28

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic osteosarcoma MedDRA version: 21.1 Level: PT Classification code 10031294 Term: Osteosarcoma metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Product Name: CISPLATINO Product Code: [CISPLATINO] Pharmaceutical Form: Solution for infusion in administration system INN or Proposed INN: CISPLATINO CAS Number: 15663-27-1 Current Sponsor code: CDP

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - High-grade metastatic osteosarcoma - Age at diagnosis = 12 years (or with skeletal maturity) and = 40 years - ECOG Performance status = 2 or Lansky = 40% - Adequate medullary, cardiac, liver and kidney function - Female subjects of childbearing age must perform a pregnancy test before entering the study - Written informed consent obtained from the patient/parent/legal representative Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 56 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Medical contraindication to the use of the drugs provided for in the study - Previous treatments with denosumab or other biphosphonates - Mental or social conditions that do not guarantee adequate compliance with the protocol, proper home management of toxicity or an adequate understanding of participation in the study - Lack of written informed consent - Organ dysfunction - Pregnancy or lactation - Uncontrolled hypocalcemia with oral calcium supplementation - Severe hypovitaminosis D - Previous history or evidence of osteonecrosis of the jaw - Dental contraindications to the use of denosumab

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluation of the effectiveness of denosumab in combination with standard chemotherapy in patients with metastatic OS.;Secondary Objective: - Overall Survival: OS - Safety and toxicity of combination treatment - Evaluation of RANK/RANKL expression, of tumor inflammatory infiltrate, both in the primitive tumor and in the metastatic sites reallocated, at diagnosis and after therapy, correlated with the treatment and response to the treatment received;Primary end point(s): 5-year Event Free Survival - EFS;Timepoint(s) of evaluation of this end point: 5 years	—

Measure

Time frame

Main Objective: Evaluation of the effectiveness of denosumab in combination with standard chemotherapy in patients with metastatic OS.;Secondary Objective: - Overall Survival: OS - Safety and toxicity of combination treatment - Evaluation of RANK/RANKL expression, of tumor inflammatory infiltrate, both in the primitive tumor and in the metastatic sites reallocated, at diagnosis and after therapy, correlated with the treatment and response to the treatment received;Primary end point(s): 5-year Event Free Survival - EFS;Timepoint(s) of evaluation of this end point: 5 years

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Countries

Italy

Contacts

Public ContactS.C. Pediatria Oncologica

Fondazione IRCCS Istituto Tumori Milano

cristina.meazza@istitutotumori.mi.it0223902590

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026