Skip to main content

Table 3 Scheduled visits and assessments

From: Phase II, multi-center, open-label, single-arm clinical trial evaluating the efficacy and safety of Mycophenolate Mofetil in patients with high-grade locally advanced or metastatic osteosarcoma (ESMMO): rationale and design of the ESMMO trial

Procedures Study Visits
SV C1w0 C1w1 C1w2 C1w4 C2w2 C2w4 C3w2 C3w4 C4w2 C4w4 FV
Informed consent obtained ×            
Inclusion/exclusion criteria assessments ×            
History taking ×            
Physical examination × × × × × × × × × × × ×
ECOG status ×            
Electrocardiogram ×            
Lab test for complete blood count ×    × × × × × × × × ×
Lab test for fasting blood glucose ×            
Other lab tests(a) ×    × ×   ×   ×   × ×
Circulating tumor cells   ×(b) ×(b) ×   ×   ×   ×   
Biobank collection ×     ×   ×   ×   × ×
Urine analysis(c) ×    × ×   ×   ×   × ×
Stool examination ×            ×
Pharmacokinetic study(d), (e)   × ×          
Pain score & Quality of life   ×    ×   ×   ×   × ×
Review of concomitant medications × × × × × × × × × × × ×
Monitoring for adverse events    × × × × × × × × × ×
Tumor assessment(f) ×       ×     ×  
  1. SV = screening visit; Cxwy = cycle x week y; FV = final visit. (a) Lab tests include Na, K, Cl, HCO3, Ca, Mg, P, albumin, AST, ALT, ALP, total bilirubin, direct bilirubin, BUN, Cr, PT, PTT, INR, and LDH; (b) Blood obtained from the pharmacokinetic study will be used for measurement of circulating tumor cells on C1W0 and C1W1 so that no additional blood samples will be collected; (c) Urine analysis includes a urine pregnancy test for a female patient of childbearing age; (d) Blood samplings (at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 h); (e) Additional samplings for drug monitoring may be required when drug dosage is modified (after ≥7 days of drug administration with an adjusted dose level); (f) Tumor assessment by a computerized tomography (CT) scan (of the chest ± other organs, if required) or magnetic resonance imaging (MRI), done at baseline, 8 ± 1 weeks and 16 ± 1 weeks after initiation of study drug administration; in case of objective tumor response (complete response or partial response), confirmatory imaging studies will be performed at least 4 weeks after initial documentation of response