Status:
RECRUITING
Metformin as Maintenance Therapy in Patients With Bone Sarcoma and High Risk of Relapse
Lead Sponsor:
Istituto Ortopedico Rizzoli
Conditions:
Osteosarcoma
Ewing Sarcoma
Eligibility:
All Genders
14+ years
Phase:
PHASE2
Brief Summary
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 th...
Detailed Description
MATERIALS \& METHODS The study is divided in two groups 1\. Group 1-Localized osteosarcoma that have reported a post neoadjuvant chemotherapy primary tumor necrosis ≤ 60% Metformin will be administra...
Eligibility Criteria
Inclusion
- Non metastatic osteosarcoma patients with necrosis ≤ 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).
- ≥ 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 ≥ 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
- 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.
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT04758000
Start Date
March 1 2021
End Date
July 1 2027
Last Update
August 4 2023
Active Locations (1)
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1
Chemotherapy Div, Istituto Ortopedico Rizzoli
Bologna, Italy