Metformin for Bone sarcoma | Osteosarcoma | Ewing sarcoma

Inclusion criteria

• {"criterion_text":"- Age ≥ 10 years\n- Body weight ≥ 30 kg\n- Patients with localized Osteosarcoma with necrosis ≤ 60% at the end of postoperative chemotherapy (within 45 days of completion)\n- Patients with osteosarcoma or Ewing's sarcoma rendered disease-free after first relapse (within 45 gg of surgery or chemotherapy termination)\n- Patients not included in other protocols\n- Patients able to swallow\n- Screening within 30 days of chemotherapy termination (or relapse surgery)\n- Starting treatment within 30 from screening\n- 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"}

Exclusion criteria

• {"criterion_text":"- Type I or II diabetes\n- Patient with metastatic disease\n- 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)\n- Patients with renal insufficiency (GFR < 70 ml/min).\n- Patients with acute conditions potentially affecting renal function such as dehydration, severe infection, shock\n- Patients with liver failure, acute alcohol intoxication, alcoholism.\n- Patients with conditions that can cause tissue hypoxia: decompensated heart failure, respiratory failure, recent myocardial infarction, shock.\n- Patient who does not fit the inclusion criteria\n- 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."}

Primary endpoints

• {"endpoint_text":"- Event Free Survival","definition_or_measurement_approach":"EFS (Event Free Survival) will be evaluated in patients with osteosarcoma and Ewing's sarcoma at high risk of relapse compared with that found in historical controls."}

Secondary endpoints

• {"endpoint_text":"- unexpected metformin toxicity","definition_or_measurement_approach":"Evaluate metformin toxicity by blood tests and clinical assessment (as stated in secondary objectives)."}
• {"endpoint_text":"- patient therapy compliance with EORTC QLQ-C30 questionnaire","definition_or_measurement_approach":"Therapy compliance assessed with age-adjusted EORTC QLQ-C30 questionnaire for adults (as stated in secondary objectives)."}

Italy

Latest Decision Or Authorization Date

29-07-2024

Number Of Sites

4

Number Of Participants

67

Primary sponsor

Full Name

Istituto Ortopedico Rizzoli

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy