patients with differentiated thyroid cancer metastasis with minimally progressive development MedDRA version: 20.0 Level: SOC Classification code 10029104 Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps) System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: GLUCOPHAGE
Product Name: Glucophage unidie 1000 MG
Product Code: [nd]
Pharmaceutical Form: Tablet
Current Sponsor code: 68UCS2020
Concentration unit: mg milligram(s)
Concentration type: eq
Sponsors
ENTE OSPEDALIERO OSPEDALI GALLIERA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age> 18 years. 2) high-risk DTC (according to ATA 2015 classification) histologically proven; 3) total thyroidectomy and previous radiometabolic therapy with 131I (administered activity between 2.96 GBq and 3.7 GBq); 4) no evidence of distant metastases at disease onset; 5) evidence of structural relapse over time treated with a second administration of RAI (activity from 5.5 GBq to 7.4 GBq). 6) absence of cancer-specific metastatic symptoms and absence of impending cancer-specific symptoms; 7) no iodine-greedy metastases after the second RAI; 8) Patients with evidence of slow disease progression (e.g. time to doubling of lung metastasis volume> 1 year) not susceptible to further surgery and candidates for active surveillance; 9) biochemical progression (i.e. increase in Tg levels in the last year). 10) preserved renal function (creatinine clearance estimated by Cockcroft-Gault formula = 60 mL / min;) 11) normal liver function (values of AST, ALT, Total Bilirubin, gammaGT and alkaline phosphatase> 1.5 times the upper limit of the normal range) 12) Signature of informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: da mettere in inglese
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Valuate the power of metformin in asymptomatic patients with high-risk DTC, i.e. individuals with minimally progressive metastatic disease without specific symptoms. This will be evaluated on the basis of two main endpoints: 1) "clinical benefit rate", namely the percentage of patients with complete or partial response or with stable disease 2)Tg level over the time;Secondary Objective: na;Primary end point(s): 1) Progression-free survival (PFS); 2) Tg levels have been trending over time.;Timepoint(s) of evaluation of this end point: at least 18 months | — |
Countries
Italy
Contacts
Public ContactS.C. Medicina Nucleare
E.O. Ospedali Galliera
Outcome results
None listed