2024-515639-32-00招募中2 期
Metformin as maintenance therapy in bone sarcomas at high risk of relapse
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 67
- 试验地点
- 4
- 主要终点
- Event Free Survival
研究概览
简要总结
To evaluate EFS (Event Free Survival) in patients with osteosarcoma and Ewing's sarcoma at high risk of relapse compared with that found in historical controls.
研究设计
- 分配方式
- Non-randomized
- 主要目的
- 1
- 盲法
- None
入排标准
- 年龄范围
- 0 years 至 65+ years（65+ Years, 0-17 Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 10 years
- •Body weight ≥ 30 kg
- •Patients with localized Osteosarcoma with necrosis ≤ 60% at the end of postoperative chemotherapy (within 45 days of completion)
- •Patients with osteosarcoma or Ewing's sarcoma rendered disease-free after first relapse (within 45 gg of surgery or chemotherapy termination)
- •Patients not included in other protocols
- •Patients able to swallow
- •Screening within 30 days of chemotherapy termination (or relapse surgery)
- •Starting treatment within 30 from screening
- •Normal renal function (creatinine <1.3 mg/L, creatinine clearance ≥70 mL/min) and liver function (serum total bilirubin <1.2 mg/dL, except patients with Gilbert syndrome), AST and ALT <1.8 times the value above the normal range
排除标准
- •Type I or II diabetes
- •Patient with metastatic disease
- •Patients with hypersensitivity to the active ingredient or any of the excipients Patients with any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis)
- •Patients with renal insufficiency (GFR < 70 ml/min).
- •Patients with acute conditions potentially affecting renal function such as dehydration, severe infection, shock
- •Patients with liver failure, acute alcohol intoxication, alcoholism.
- •Patients with conditions that can cause tissue hypoxia: decompensated heart failure, respiratory failure, recent myocardial infarction, shock.
- •Patient who does not fit the inclusion criteria
- •Pregnant or lactating women or women of childbearing age who cannot rule out pregnancy status (possibly ruled out by serological pregnancy test (hCG research)), according to CTFG recommendations.
结局指标
主要结局
Event Free Survival
Event Free Survival
次要结局
- unexpected metformin toxicity
- patient therapy compliance with EORTC QLQ-C30 questionnaire
研究者
Martina Piccinni Leopardi
Scientific
Istituto Ortopedico Rizzoli
研究点 (4)
Loading locations...
相似试验
进行中（未招募）
1 期
Administration of Metformin as maintenance therapy in patients with osteosarcoma or Ewing's sarcomaOsteosarcoma and Ewing's SarcomaMedDRA version: 20.0Level: PTClassification code 10023676Term: Lactic acidosisSystem Organ Class: 10027433 - Metabolism and nutrition disordersMedDRA version: 20.1Level: LLTClassification code 10000491Term: Acidosis lacticSystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2020-002579-37-ITISTITUTO ORTOPEDICO RIZZOLI60
进行中（未招募）
1 期
Metformin as maintenance therapy in bone sarcomas at high risk of relapsebone sarcomaMedDRA version: 20.0Level: HLTClassification code: 10039498Term: Bone sarcomas Class: 10029104CTIS2024-515639-32-00Istituto Ortopedico Rizzoli67
招募中
2 期
Metformin as Maintenance Therapy in Patients With Bone Sarcoma and High Risk of RelapseOsteosarcomaEwing SarcomaNCT04758000Istituto Ortopedico Rizzoli67
招募中
2 期
Randomised trial evaluating mifamurtide in combination with standard chemotherapy in patients with high-grade osteosarcoma at high risk of relapse.2024-514780-26-00Unicancer315
招募中
2 期
To evaluate the efficacy and safety of regorafenib in patients with refractory primary bone tumors.2024-514720-17-00Instytut Matki I Dziecka30