Baseline assessment, follow-up & monitoring
toxicity, tumour
DISEASE, TUMOUR
At baseline, patients had a clinical assessment, radiological assessment and plasma sampling. As part of a translational sub-study, plasma samples were obtained and banked for future biomarker research, with an optional tumour biopsy at baseline and at week 6. Assessments were performed at week 12, week 24 and then 3 monthly. After 18 months, assessments were 6 monthly. Assessments included clinical examination, compliance evaluation, laboratory determinations and tumour assessment by CT scan chest/abdomen/pelvis (plus other imaging/clinical measurements appropriate to site of disease) to monitor measurable lesions using RECIST 1.1 criteria. [Patients were followed up whilst on therapy for efficacy & toxicity, until either progression or 30 days after cessation of trial therapy (whichever was later). Thereafter, patients were tracked for overall survival only.