Actively Recruiting
Metformin as Maintenance Therapy in Patients With Bone Sarcoma and High Risk of Relapse
Led by Istituto Ortopedico Rizzoli · Updated on 2023-08-04
67
Participants Needed
1
Research Sites
330 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 literature to be around 21% (Leary SE 2013) and 16% (Tirtei E 2017). The EFS at ONE YEAR after first relapse in Ewing's sarcoma is inferior to 20% (Barker 2005, Ferrari S 2015). A maintenance therapy with low toxicity in these high risk patients could be an option. Metformin has been reported to a reduce the incidence of different type of cancer in diabetic patients. Metformin is well tolerated in diabetics an it is used in other conditions in non diabetic, as ovarian polycystic syndrome, metabolic syndrome and obesity. Metformin has been employed as chemoprevention related to its mechanism of action in breast cancer (NCT01101438 ) and in pediatric cancer together with chemotherapy (NCT01528046). This study aim to explore the effectiveness of metformin (a low cost and well tolerated drug) as maintenance therapy in osteosarcoma and Ewing sarcoma patients at high risk of relapse.
CONDITIONS
Official Title
Metformin as Maintenance Therapy in Patients With Bone Sarcoma and High Risk of Relapse
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Non metastatic osteosarcoma patients with necrosis 60% after post-operative chemotherapy within 45 days of treatment end
- Osteosarcoma or Ewing sarcoma patients free from disease after first relapse within 45 days from local surgery or chemotherapy end
- Patients aged 14 years or older
- Patients not participating in other clinical studies
- Patients able to swallow medication
- Screening within 30 days of chemotherapy end or relapse
- Start therapy within 30 days of screening
- Normal kidney function (creatinine <1.3 mg/L, clearance 6 70 ml/min) and liver function (bilirubin <1.2 mg/dL, AST and ALT <1.8 times normal, except Gilbert syndrome)
You will not qualify if you...
- Patients with type B diabetes
- Patients with metastatic disease
- Patients with acute metabolic acidosis (lactic acidosis or diabetic ketoacidosis)
- Patients with kidney problems (GFR < 70 ml/min) or acute kidney-altering conditions such as dehydration, severe infection, shock
- Patients with liver failure including acute alcohol intoxication or alcoholism
- Patients with conditions causing low tissue oxygen such as decompensated heart failure, respiratory failure, recent heart attack, or shock
- Patients who do not meet inclusion criteria
- Pregnant or breastfeeding patients, or women who cannot exclude pregnancy confirmed by serum pregnancy test
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Chemotherapy Div, Istituto Ortopedico Rizzoli
Bologna, Italy
Actively Recruiting
Research Team
A
Alessandra Longhi, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here