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Table 1 Schedule of enrolment, interventions, and assessments of the experimental arm

From: Perioperative systemic therapy and cytoreductive surgery with HIPEC versus upfront cytoreductive surgery with HIPEC alone for isolated resectable colorectal peritoneal metastases: protocol of a multicentre, open-label, parallel-group, phase II-III, randomised, superiority study (CAIRO6)

  Study period
Enrolment/allocation Post-allocation Close-out
Outpatient clinics Neoadjuvant treatment CRS-HIPEC Adjuvant treatment 3 months after CRS-HIPEC 6 months after CRS-HIPEC 9 months after CRS-HIPEC Every 6 months 5 years after randomisation
Enrolment/allocation
 Eligibility screen X         
 Informed consent X         
 Allocation X         
Interventions
 Chemotherapy   X   X      
 Bevacizumab   Xa        
 CRS-HIPEC    X       
 Thoracoabdominal CT   Xb    X   X X X
 Questionnaires X Xc    X X X X X
 Translational research: blood X Xd Xe Xd X   X X X
 Translational research: tissue    X       
Assessments
 Baseline characteristics X         
 Feasibility of systemic therapy   X X X      
 Safety/toxicity of systemic therapy   X X X      
 Radiological response   X        
 Histopathological response    X       
 Surgical characteristics    X       
 Postoperative morbidity    X   X     
 Progression-free survival   X X X X X X X X
 Disease-free survival    X X X X X X X
 Overall survival   X X X X X X X X
 Health-related quality of life X X X   X X X X X
 Costs X X X   X X X X X
  1. CRS-HIPEC cytoreductive surgery with hyperthermic intraperitoneal chemotherapy, CT computed tomographyaAdded to the first three (CAPOX) or four (FOLFOX/FOLFIRI) cycles of neoadjuvant chemotherapy
  2. bAfter three (CAPOX with bevacizumab) or four (FOLFOX/FOLFIRI with bevacizumab) cycles
  3. cAfter completion of neoadjuvant systemic therapy, before CRS-HIPEC
  4. dBetween the first and the second cycle of (neo)adjuvant systemic therapy
  5. e1 day before CRS-HIPEC and 7 days after CRS-HIPEC