A nationwide randomized controlled trial on additional treatment for isolated local pancreatic cancer recurrence using stereotactic body radiation therapy (ARCADE)

Table 1 Schedule of enrolment, intervention, and assessments according to the SPIRIT guidelines

Timepoint	Study period
	Identification	Allocation	Post-allocation
	Recurrence diagnosis		pre-SBRT	SBRT	After completing therapy^d
PACAP registry, TwiCs, and PROMs informed consent	X
Histological confirmation PDAC recurrence	X
Informed consent for additional SBRT (investigational arm)		X
SBRT 5x8 Gy				X
History and physical examination			X		Every 3 months
Laboratory investigation including tumor markers			X		Every 3 months
MRI scan chest and abdomen			X^b
CT scan chest and abdomen			X		At 3, 6, and every subsequent 6 months
Fiducial marker-placing			X^c
QoL questionnaires^a	X				At 3, 6, 9, 12, and 18 months after recurrence diagnosis

^aThe following questionnaires are used: general questions, questions on exocrine pancreas insufficiency (EPI), non-disease specific health-related quality-of-life (HRQL) (EQ-5D-5L), cancer-specific HRQL (EORTC QLQ-C30), tumor-specific HRQL (EORTC QLQ-PAN26), neuropathy (EORTC QLQ-CIPN20), happiness, hospital anxiety and depression scale (HADS), worry of progression of cancer scale (WOPS; modified from ways of coping scale (WOCS)
^bOnly for patients treated at the UMC Utrecht or Amsterdam UMC
^cOnly for patients treated at the Erasmus MC
^dFor patients receiving chemotherapy, this will be after their chemotherapy. During chemotherapy they will be treated according to standard of care. For patients receiving best supportive care, this will be after radiotherapy

ISSN: 1745-6215