2024-514780-26-00招募中2 期
SARCOME 13 / OS2016 - A Multicentre, Randomised, Open-label, Phase 2 trial of mifamurtide combined with post-operative chemotherapy for newly diagnosed high risk osteosarcoma patients (metastatic osteosarcoma at diagnosis or localised disease with poor histological response)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Unicancer
- 入组人数
- 315
- 试验地点
- 39
- 主要终点
- Event-free survival (EFS) estimated from the randomisation date to the time of first event (loco-regional or distant relapse or progression, second malignancy, death from any cause). Observations will be censored at the date of last follow-up visit for the patients remaining in first complete remission.
研究概览
简要总结
To evaluate the impact on efficacy (event-free survival, EFS) of mifamurtide administered during 36 weeks as add-on treatment to post-operative chemotherapy, compared to post-operative chemotherapy alone, in first-line treatment of patients >2 years and ≤ 50 years with high-risk osteosarcoma (metastatic at diagnosis or localised with poor histological response to pre-operative chemotherapy).
入排标准
- 年龄范围
- 0 years 至 64 years（0-17 Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •At diagnosis : All newly diagnosed, biopsy-proven, high-grade osteosarcoma, whatever the initial extension of the disease
- •For the randomisation : Osteosarcoma classified as high risk because of at least one risk factor
- •For the randomisation : Pre-operative chemotherapy
- •For the randomisation : Screening laboratory values must meet the following criteria (using CTCAE v5) and should be obtained within 7 days prior to randomisation
- •For the randomisation : Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) done within 7 days prior to randomisation
- •For the randomisation : Provision of dated and signed written informed consent for the randomised trial prior to any study specific procedures, sampling and analyses.
- •For the randomisation : Patient fit to undergo protocol treatment and follow-up
- •For the randomisation : Affiliation to a social insurance regimen
- •At diagnosis : Age >2 years and ≤50 years
- •At diagnosis : Normal haematological, renal, cardiac and hepatic functions
- •At diagnosis : Planned neoadjuvant chemotherapy
- •At diagnosis : Written informed consent from patients and/or their parents/guardians before enrolment and any study-related procedure
- •At diagnosis : Affiliation to a social insurance regimen
- •For the randomisation : Patient with a histologically proven, confirmed by expert pathologists panel (before surgery at the latest), high-grade osteosarcoma
- •For the randomisation : Registered at diagnosis into the study
- •For the randomisation : Primary tumour resected after pre-operative chemotherapy
排除标准
- •Low grade osteosarcoma, parosteal or periosteal osteosarcoma
- •Concurrent use with high-dose non-steroidal anti-inflammatory drugs (NSAIDs, cyclooxygenase inhibitors)
- •Inflammatory or auto-immune disease, allergy or asthma requiring a chronic use of steroid treatment that cannot be stopped
- •Patients with positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
- •Patients with positive tests for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating active or chronic infection
- •Prior history of other malignancies other than osteosarcoma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix) unless the patient has been free of the disease for at least 3 years
- •Osteosarcoma with multiple metastases for whom complete removal is not expected to be feasible even after shrinkage with chemotherapy
- •Progressive disease at any site during initial pre-operative chemotherapy, confirmed before randomisation time, with exception of patients with progressive disease of the primary tumour who had a complete resection at surgery
- •Any medical condition precluding treatment with protocol post-operative chemotherapy
- •Fractional Shortening < 28% or LVEF< 50% before treatment (only for API post-operative chemotherapy) by echocardiogram or Muga scan
- •Pregnancy or breast-feeding
- •Hypersensitivity to the active substance or to any of the excipients
- •Concurrent use of immunodepressive treatment such as cyclosporine, tacrolimus or other calcineurin inhibitors
结局指标
主要结局
Event-free survival (EFS) estimated from the randomisation date to the time of first event (loco-regional or distant relapse or progression, second malignancy, death from any cause). Observations will be censored at the date of last follow-up visit for the patients remaining in first complete remission.
Event-free survival (EFS) estimated from the randomisation date to the time of first event (loco-regional or distant relapse or progression, second malignancy, death from any cause). Observations will be censored at the date of last follow-up visit for the patients remaining in first complete remission.
次要结局
- Overall survival (OS) from the randomisation date to the date of death, whatever the cause of death.
- Progression Free-survival (PFS) from the randomisation date to the date of disease progression (radiological or clinical) or death of any cause, whichever occurs first. Observations will be censored at the date of last follow-up visit for the patients remaining in first complete remission.
- Feasibility of the planned treatment with calculation of cumulative dose and dose intensity of mifamurtide and chemotherapy
- Safety : all adverse events (NCI-CTCAE v5) will be analysed except AE unequivocally related to the underlying disease or its progression/relapse.
- Long-term toxicity
- Biomarkers to evaluate mifamurtide mechanisms of action and resistance
研究者
Nourredine AIT RAHMOUNE
Scientific
Unicancer
研究点 (39)
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