Metformin as maintenance therapy in bone sarcomas at high risk of relapse

Other illness

• 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 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.

Lab values

• Patients with renal insufficiency (GFR < 70 ml/min).

Age

• 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.

Other

• Patient who does not fit the inclusion criteria

• 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