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Metformin as maintenance therapy in bone sarcomas at high risk of relapse
EU CTIS ID: 2024-515639-32-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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.
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.