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Metformin as Maintenance Therapy in Patients With Bone Sarcoma and High Risk of Relapse

RecruitingPhase 2Ages 14 Years - anyAllIstituto Ortopedico Rizzoli
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In plain words

What the trial is, and whether it could suit you

Primitive bone sarcoma are rare tumors with low options of therapy for patient treatment. 1. OSTEOSARCOMA VERY POOR RESPONDER COHORT. Necrosis on primitive localized osteosarcoma represents one of the principal prognostic factors. Nowadays, for localized osteosarcoma there is no maintenance therapy that have shown to be effective. In ISG-OS1 study in patients with necrosis \< 60% had an event free survival (EFS) at 3 yrs of 20% (Ferrari S ) in a more recent analysis (Tsuda Y 2020) patients with a necrosis \<60% had a 3 y EFS of 35% . 2. OSTEOSARCOMA AND EWING'S SARCOMA AFTER FIRST RELAPSE Maintenance therapy after Complete Remission occurring after Ewing's sarcoma or osteosarcoma patients is not a standard rule. These patients when free from disease, after first relapse, are more likely to face a second relapse. EFS at ONE YEAR after first relapse in osteosarcoma is shown in litera

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Non metastatic osteosarcoma patients with necrosis โ‰ค 60 % in the end of post-operatory chemotherapy treatment (within 45 days.from the end of chemotherapy treatment). * Osteosarcoma or Ewing sarcoma patients free from the disease after first relapse (within 45 days.from the local surgery or 45 days from the end of chemotherapy treatment). * โ‰ฅ 14 years. * Patient should not be participating in other clinical study. * Patients should be able to swallow. * Screening up to 30 days from the end of chemotherapy treatment or relapse. * Start therapy up to 30 days from the screening. * Normal renal function (creatinine \<1,3 mg/L, clearance creatinine โ‰ฅ 70 ml/min) end liver function (total serum bilirubina \<1,2 mg/dL, except Gilbert syndrome patients), AST e ALT \<1,8 times the normal range value Exclusion Criteria: * Type B diabetic patient * Metastatic patients * Patients with acute metabolic acidosis (lactic acidosis, diabetic ketoacidosis). * Patients with renal insufficiency (GFR \< 70 ml/min). * Patients with acute conditions that could cause kidney alterations as dehydration, severe infection and shock. * Patients with hepatic insufficiency as acute alcohol intoxication and alcoholism. * Patients with medical conditions that could cause tissue hypoxia: decompensated heart failure, respiratory failure, recent myocardial infarction, shock. * Patient who does not meet the inclusion criteria * Pregnant and breastfeeding patients, or young women at childbearing age who cannot exclude the state of pregnancy (possibly excluded by serum pregnancy test (BhCG test), in accordance with the recommendations of the CTFG.
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What it tests

  • Metformin Hydrochloride
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Where

1 site
Chemotherapy Div, Istituto Ortopedico Rizzoli
Bologna, Italy
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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