Table 3.
Overview of study assessments of the TALASUR trial
|
Screening (within 14 days prior C1D1) |
During treatment (1 cycle = 28 days) |
End of treatment (within 4 weeks after last dose) |
Follow-up after the end of treatment | Overall survival after disease progression | ||
|---|---|---|---|---|---|---|
| Every cycle | ||||||
| D1 | D15 | |||||
| Informed Consent should be done before any study procedures | ||||||
| Informed consent | ✔ | |||||
| Inclusion/Exclusion Criteria | ✔ | |||||
|
Demographics - Medical/surgical history and prior treatment for urothelial carcinoma |
✔ | |||||
| Prior and Concomitant Medication Review | ✔ | ✔ | ✔ | ✔ | ||
| Trial treatment administration | ✔ | ✔ | ||||
| Complete physical, weight, height (only at baseline), ECOG, vital signs | ✔a | ✔ | ✔ | ✔ | ✔i | |
| Adverse Events (AEs) collection | ✔ | ✔ | ✔ | ✔i | ||
| CBC, platelets, hemoglobin | ✔a | ✔ | ✔ | ✔ | ||
| Blood biochemistry | ✔a,b |
✔b (cycle 1: within 7 days prior C1D1) |
✔g | ✔b | ||
| Coagulation | ✔a,c | ✔(if clinically indicated) | ||||
| Thyroid-function testing: thyroid-stimulating hormone [TSH], free T4 | ✔a | ✔h | ✔ | |||
| HIV, HBV and HCV serology | ✔a,d | |||||
| Serum or urine pregnancy test (if applicable) | ✔a | ✔ | ||||
| Urinalysis | ✔a,e | ✔(if clinically indicatede | ✔(if clinically indicated)e | |||
| ECG | ✔(within 28 days prior C1D1) | ✔(if clinically indicated) | ||||
| Tumor imagingf | ✔(within 28 days prior C1D1) | ✔(Every 8 weeks) | ✔ | ✔j | ||
| Quality of life (QLQ-C30 and EQ-5D) | ✔a | ✔(Every 8 weeks) | ✔ | |||
| Patient diary | ✔ | |||||
| Survival status | ✔k | |||||
| BLOOD and TUMOR BANKING for further ancillary biological studies for patients having given their specific informed consent | ||||||
| Blood samples | ✔l | |||||
| Fixed primitive tumor sample (or 20 slides) | ✔ | |||||
aWithin 7 days before inclusion
bSerum biochemistry at inclusion, Day 1 of each cycle and end of treatment: Sodium, potassium, chloride, corrected calcium, total bilirubin, creatinine, glucose, albumin, total protein, GGT, ALT, AST, alkaline phosphatase, LDH, lipase, magnesium
cINR and aPTT or PTT
dHuman Immunodeficiency Virus, Hepatitis B surface antigen (HBsAg), antibodies against HBsAg, total hepatitis B core antibody (HBcAb); hepatitis C virus antibody (anti-HCV)
eIf ≥ 2 + , collect 24-h urine collection
fTumor assessments will include all known or suspected disease sites. Imaging includes chest, abdomen, and pelvis computed tomography (CT) or magnetic resonance imaging (MRI) scans if CT is contra-indicated. Bone scans or brain MRI scans may be realised if clinically indicated by clinical investigator. Bone scans will only be repeated during study as clinically indicated. The CT and MRI scans should be performed with contrast agents unless contraindicated for medical reasons. The same imaging technique used to characterize each identified and reported lesion at baseline will be employed in the following tumor assessments
gSerum biochemistry at Day 15 of each cycle: Sodium, potassium, chloride, corrected calcium, total bilirubin, creatinine, glucose, albumin, total protein, GGT, ALT, AST, alkaline phosphatase, LDH
hOnly on Day 1 of cycle 2, 3 and every 2 cycles
iAt one and 3 months after the last dose
jFor patients who have stopped the treatment for another reason than disease progression: tumoral evaluation every 8 weeks up to disease progression
kEvery 3 months
lBlood samples at baseline