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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