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

ProceduresStudy Visits
SVC1w0C1w1C1w2C1w4C2w2C2w4C3w2C3w4C4w2C4w4FV
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
\