Table 1. Overview of study procedures.
| Screening (T<0) | Prerandomisation | Randomisation (T=0) | Before and after every cycle, until progression | Each 8–12 weeks | After 1 month | After 3 months | After 6 months | After 9 months | After 12 months | End of study | |
| Informed consent | E | ||||||||||
| Geriatric-8 | E | ||||||||||
| Inclusion/exclusion | X | ||||||||||
| Patient/tumour characteristics | X | ||||||||||
| Laboratory analysis* | X | X | |||||||||
| Toxicity | X | ||||||||||
| Radiologic evaluation† | X | X | |||||||||
| Dose reductions | X | ||||||||||
| Cycles, n | X | ||||||||||
| Hospitalisations | X | ||||||||||
| Survival | X | X | |||||||||
| EQ-5D‡ | E | E | E | E | E | E | |||||
| EORTC Core QLQ-C30‡ | E | E | E | E | E | E | |||||
| Katz ADL‡ | E | E | E | E | E | E | |||||
| Lawton IADL‡ | E | E | E | E | E | E | |||||
| Home and informal care‡ | E | E | E | E | E | E | |||||
| MNA | E | ||||||||||
| TICS-M | E | ||||||||||
| PHQ-2 | E |
Window for questionnaires: ±4 weeks.
X=procedures are standard of care. E=extra procedure in study context.
Laboratory analyses should at least include total blood count, kidney and liver function.
Radiologic evaluation: performed according to local standard practice (CT scan, positron emission tomography (PET) scan and/or MRI scan).
Follow-up questionnaires will be performed until disease progression or until 12 months after randomisation in case of no disease progression.
ADLactivities of daily livingEORTCEuropean Organisation for Research and Treatment of CancerEQ-5DEuroQol-5DIADLInstrumental Activities of Daily LivingMNAMini Nutritional AssessmentNnumberPHQ-2Patient Health Questionnaire-2TICS-MModified Telephone Interview for Cognitive Status