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Table 2 Trial flow chart of the SULTAN study

From: Treatment intensification with hepatic arterial infusion chemotherapy in patients with liver-only colorectal metastases still unresectable after systemic induction chemotherapy – a randomized phase II study -- SULTAN UCGI 30/PRODIGE 53 (NCT03164655)- study protocol

VISITSScreening after 2 to 6 months of CTBaseline Within 21 days before randomizationTreatment periodEnd of treatment 2 to 4 weeks after the last administration of the study treatmentFollow-up Every 2 monthsfor minimum 12 months to 48 months after randomization
  Every 2 weeksEvery 28 daysEvery 8 weeks  
Inclusion / non-inclusion criteria x     
Signed informed consent formx      
Randomization (R) x     
Medical history and prior treatment history x     
Central review (verification on the unresecability of CRLM) x     
PHYSICAL EXAMINATIONa
 Complete clinical examination & vital signs xxxxxx
 Performance status (ECOG) xxxxxx
 Toxicities/adverse events/signs and symptoms xxxxxx
 Concomitant treatments xxxxx 
PARACLINICAL EXAMINATION
 Thoraco-abdomino and pelvic CT scan and/or liver MRI x  x x
 Angiogram or scintigraphic hepatic infusion in the experimental arm xb xc   
 ECGa xxxx  
BIOLOGICAL TESTSa
 Hematology (neutrophils, platelets, haemoglobin), xxxxx 
 Biochemistry (including kalemia, magnesemia calcemia, glycemia) xxxxx 
 Liver function (alkaline phosphatase, total and conjugated bilirubin, AST, ALT, LDH) xxxxx 
 Albuminemia, Protidemia xxxxx 
 INR x     
 Renal function (creatininemia, urea, calculated creatine clearance) xxxxx 
 Proteinuria xxdxdxd  
 Pregnancy test x xx  
 Tumor marker: CEA + CA 19.9 x  x  
QUALITY of LIFE QUESTIONNARY
 QLQ-C30 + QLQ-LMC21 x  x xe
  1. awithin 7 days of randomization for baseline assessment and to be realized before and after oxaliplatin intravenous or intrahepatic arterial infusion (HAI); after randomization; bafter randomization and before the start of intra-arterial oxaliplatin; cat least every 28 days during the treatment phase, more often if needed, donly for patients who received bevacizumab, eUntil progression for a maximum 2 years