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

Studio Clinico

Patologia: Altre neoplasie

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Monocentrico

Randomizzato: No

Fase di studio: II

Linee di trattamento: Mantenimento

Criteri di inclusione: 

- 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.

Criteri di esclusione: 

- 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.

Trattamento sperimentale: 

Metformin will be administrated according with patients body mass index (BMI). The study is divided into 2 groups.

Group 1: Localized osteosarcoma that have presented a response ≤ 60% to the pre-operatory chemotherapy).
Group 2: Osteosarcoma and Ewing sarcoma patients with complete remission after the first relapse.

Trattamento di controllo: 

-

Centri partecipanti

Nord Italia

Istituto Ortopedico Rizzoli
Via Pupilli 1 - 40136 Bologna - BO

Riferimento: Dr.ssa Alessandra Longhi
Telefono: 051644516
Email: alessandra.longhi@ior.it

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2020-002579-37

Data di inserimento: 01.08.2023

Promotore

Istituto Ortopedico Rizzoli

Principal Investigator ITALIA

Istituto Ortopedico Rizzoli, Bologna

Riferimento: Dr.ssa Alessandra Longhi

Telefono: 051644516

Email: alessandra.longhi@ior.it

Localita: Bologna

 

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