Selective Internal Radiation Therapy (SIRT) with yttrium-90 resin microspheres plus standard systemic chemotherapy regimen of FOLFOX versus FOLFOX alone as first-line treatment of non-resectable liver metastases from colorectal cancer: the SIRFLOX study

Table 3 SIRFLOX study assessment schedule

	Screening	During chemotherapy			Post-progression follow-up
Evaluation/examination	(≤28 d before randomisation)	Day 1	Day 3 or 4 of cycle 1	Every 2 weeks ±1 week^a	(every 12 weeks)
Informed consent	X
Demographics	X
Medical history	X
Concomitant illnesses	X
Concurrent medications	X	X	X	X
Clinical assessment and physical examination	X	X		X
Performance status	X	X		X
Haematology^b	X	X		X
Biochemistry^c	X	X		X
Pregnancy test	X
Serum CEA	X			X^d
CT of chest/abdomen/pelvis	X			X^e	X
Assessment for resection	X			X^e
Hepatic angiogram^f		X^g
^99mTc-MAA lung shunt study^f		X^g
Adverse events	From consent until 28 days after the last dose of protocol chemotherapy
EQ-5D HRQoL	X			X^h
EORTC QLQ-C30 HRQoL	X			Xⁱ
Ongoing review of treatment and survival					X

^aBefore each cycle of chemotherapy unless otherwise stated.
^bMeasurement of haemoglobin, platelets, white blood cells, absolute neutrophils and absolute lymphocytes.
^cUrea, creatinine, liver enzymes, alkaline phosphatase, bilirubin and albumin.
^dEvery 4 weeks.
^eEvery 8 weeks.
^fIntervention arm only.
^g7 days ±4 days before SIRT.
^hEQ-5D questionnaire completed at 3, 6, 12, 24, 36 months, and annually thereafter.
ⁱ4 weeks and 12 months after starting treatment.
CEA = Carcinoembryonic antigen; CT = Computed tomography.

ISSN: 1471-2407