Fig. 2
Schedule of events for arm 1 of the CompARE trial. Schedule of events for treatment arm 1, concomitant cisplatin chemotherapy plus radiotherapy. *Assessment which is part of standard practice. ****Patient followed up annually for survival data for up to 5 years. #Biochemistry screen: alkaline phosphatase, alanine transferase, biocarbonate, calcium, creatinine, glomerular filtration rate, liver function tests, glucose, magnesium, potassium, sodium, total bilirubin, total protein, urea, or blood urea nitrogen. Serum or plasma analysis will include albumin, glucose, and gamma-glutamyl transferase. oCisplatin 100 mg/m2 3-weekly: full blood count and biochemistry screen to be performed 3-weekly. Cisplatin 40 mg/m2 weekly: full blood count and biochemistry screen to be performed weekly. +Toxicity and adverse events assessed during chemoradiotherapy. 1Samples collected if the patient has consented for CompARE Collect. 2Blood and oral fluid samples should also be collected at recurrence or progression (formalin-fixed paraffin-embedded tissue block or needle aspirate sample should also be collected if recurrence is confirmed by histology/cytology). 3Questionnaires to be completed by the patient in the clinic at defined visits. 4Toxicity will be reviewed using CTCAE version 4.0 and version 3.0 for scoring mucositis. The RTOG Radiation Morbidity Scoring Criteria will be used to grade late side effects due to radiotherapy. 5Neck dissection is required if persistent disease is identified in the neck on imaging (PET-CT or contrast CT or contrast MRI) at 3 months post-chemoradiotherapy treatment. The same modality PET CT or CT or MRI should be used for all arms