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)

Table 2 Schedule of enrolment, interventions, and assessments of the control arm

	Study period
	Enrolment/allocation	Post-allocation						Close-out
	Outpatient clinics	CRS-HIPEC	3 months after CRS-HIPEC	6 months after CRS-HIPEC	9 months after CRS-HIPEC	12 months after CRS-HIPEC	Every 6 months	5 years after randomisation
Enrolment/allocation
Eligibility screen	X
Informed consent	X
Allocation	X
Interventions
CRS-HIPEC		X
Thoracoabdominal CT			X	X		X	X	X
Questionnaires	X		X	X	X	X	X	X
Translational research: blood	X	X^a	X	X		X	X	X
Translational research: tissue		X
Assessments
Baseline characteristics	X
Surgical characteristics		X
Postoperative morbidity		X	X
Progression-free survival		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
Health-related quality of life	X	X	X	X	X	X	X	X
Costs	X	X	X	X	X	X	X	X

^a1 day before CRS-HIPEC and 7 days after CRS-HIPEC; CRS-HIPEC cytoreductive surgery with hyperthermic intraperitoneal chemotherapy, CT computed tomography

ISSN: 1471-2407