Table 2.

Visite schedule

	Baseline	Randomization	Treatment phase (start within 4 weeks after randomization)
Treatment Arm			Arm A (8–17 weeks)			Arm B (6–11 weeks)
			Postoperative Visit	Intermediate Visiti	Final Visit	Intermediate Visiti	Final Visit
Study week (W)	−4	0	1–4	9–13	12–17	3–7	6–11
Informed consentb(Study and translational research)	-4
Medical history incl. smoking and alcohol, demographics	X
Eligibility criteriaa	X
CT or MRI Neck	X
CT Chest/Abdomen	X
Physical examinationb	−2		X	X	X	X	X
Performance status/ASA	−2		X	X	X	X	X
Vital signsc	−2		X	X	X	X	X
Laboratory determinationsd	X		X	X	X	X	X
Panendoscopy, FFPE tissuea	X		Xe
Audiometry	X				X		X
Blood draw translat. researcha	X		X	Xj	X	Xj	X
Dental evaluation and panoramic view as indicated	X
Postoperative morbiditya	X		X	X	X
Swallowing functiona f	X		X	X	X	X	X
Nutritional evaluation	X
Quality of life assessmenta g	X		X	X	X	X	X
Health Care Utilization and Productivity lossa h	X
Monitoring AE’s/SAE’sa			X (Randomization to 28 days after the last administration of IMP and/or 5 months after randomization in this trial)
Survival			X

^aStudy specific procedures

^bincluding weight, height (only baseline)

^cblood pressure, heart rate, body temperature. ECG at baseline and as clinically indicated

^dhaematology panel (haemoglobin, platelets, WBC with neutrophils, lymphocytes, monocytes, eosinophils, and basophils), chemistry panel (sodium, potassium, calcium, serum creatinine, alkaline phosphatase, AST, ALT, total and direct bilirubin, CrP; glomerular filtration rate by MDRD, coagulation (INR, aPTT, PT). HIV and ß-HCG only at baseline and as clinically indicated

^esurgical resected tumor specimen

^fMDADI Score (Appendix E)

^gQuality of life assessments using EQ-5D-5L, EORTC QLQ-C30, QLQ H&N-43 (Appendix D)

^hSelf-report inventory based on FIMA (Appendix A) and sociodemographic evaluation (Appendix I)

ⁱ3 weeks after start of CRTX

^jwithin 2 weeks after end of CRTX