Hypofractionated radiation therapy comparing a standard radiotherapy schedule (over 3 weeks) with a novel 1-week schedule in adjuvant breast cancer: an open-label randomized controlled study (HYPORT-Adjuvant)—study protocol for a multicentre, randomized phase III trial

Table 3 Participant timeline

Assessment	All follow-up time points are taken from the date of completion of RT
	Baseline	Adjuvant RT			3–12 months every 3 months after RT	13–60 months every 6 months after RT
	Baseline	Week 1	Week 2	Week 3	3–12 months every 3 months after RT	13–60 months every 6 months after RT
Clinical evaluation	X
Eligibility checklist	X
Informed consent	X
Randomization	X
RT QA	Prior to centre initiation and throughout the trial recruitment period
RT treatment (control arm)		X	X	X
RT treatment (test arm)		X
RT verification (Control Arm)		X	X	X
RT verification (test arm)		X
SAE		X	X	X	X	X
Acute toxicity		X	X	X
FU assessments				X	X	X
EORTC QLQ C30 (control arm)	X			X	At 6, 12 and 18 months after completion of RT
FACT-B (control arm)	X			X	At 6, 12 and 18 months after completion of RT
EORTC QLQ C30 (experimental arm)	X	X			At 6, 12 and 18 months after completion of RT
FACT-B (experimental arm)	X	X			At 6, 12 and 18 months after completion of RT

Note that patients who undergo sequential tumour bed boost will have their post-radiotherapy assessment postponed till boost is completed. This would mean at the 2nd week in patients receiving 1-week RT and the 4th week in patients undergoing 3-week RT

ISSN: 1745-6215