Lapatinib-capecitabine versus capecitabine alone as radiosensitizers in RAS wild-type resectable rectal cancer, an adaptive randomized phase II trial (LaRRC trial): study protocol for a randomized controlled trial

Table 1 Schedule of events

	Screening	Random allocation (^a)	Treatment period								EOT	Surgery	EOS
	Screening	Random allocation (^a)	Day -14 (^b)	Day -7	Day 1 (^c)	Day 8 ± 3 days	Day 15 ± 3 days	Day 22 ± 3 days	Day 29 ± 3 days	Day 36 ± 3 days	Day 66 ± 3 days	Day 87–94	28 (+7) days after surgery
Informed consent	X
Inclusion/exclusion criteria	X	X
Demographics	X
Medical history	X
Concomitant medications	X	X		X	X	X	X	X	X	X	X		X
Adverse events				X	X	X	X	X	X	X	X		X
Physical examination	X	X
Vital signs	X	X		X	X	X	X	X	X	X	X		X
Weight	X	X		X	X	X	X	X	X	X	X		X
Height	X
ECOG performance status	X	X		X	X	X	X	X	X	X	X		X
Electrocardiogram (12-lead)	X										X		X
MUGA	X										X		X
Hematology	X	X		X	X	X	X	X	X	X	X		X
Serum chemistries	X	X		X	X	X	X	X	X	X	X		X
Hemostasis	X
Pregnancy test	X										X		X
CT – scan (chest, abdomen, pelvis)	X
Endoscopic ultrasound	X
Tumor sampling	X				X(^c)							X
Lapatinib (arm A)			1 250 mg/d until the last day of radiotherapy
Capecitabine (arms A and B)					825 mg/m2 twice daily from first to last day of radiotherapy
Radiation therapy					50.4 Gy in 28 fractions of 1.8 Gy, 5 days per week

EOT end of treatment visit, EOS end of study visit
(^a) Within 4 weeks of screening visit
(^b) Not more than 3 days before day -14 in arm A or more than 14 days before day 1 in arm B. In arm B, random allocation visit procedures are valid for day 1 visit if <7 days have elapsed
(^c) Arm A only: to be performed within a 3-day time window of day 1 of radiation treatment

ISSN: 1745-6215