Docetaxel, Cisplatin, and 5-fluorouracil (DCF) chemotherapy in the treatment of metastatic or unresectable locally recurrent anal squamous cell carcinoma: a phase II study of French interdisciplinary GERCOR and FFCD groups (Epitopes-HPV02 study)

Table 2 time and events table

	Screening & Inclusion		Treatment			End of treatment visit	Follow-up visit
	≤28 days	≤7 days	3 DCF or 4 mDCF cycles	Mid-treatment assessment	3 DCF or 4 mDCF cycles	28 days after last cycle	3 monthly for 3 years or death
DCF/mDCF treatment			♦^a		♦^a
Informed consent	♦
Eligibility criteria	♦
History and concomitant treatments	♦
Physical assessment including weight, height, ECOG-PS		♦
Vital signs including pulse & blood pressure		♦
12-lead ECG		♦
Pregnancy test		♦
Standard blood test^b		♦
Tumor tissue recovery	♦
Chest, abdomen and pelvis CT scan	♦			♦		♦	♦
FDG-PET-CT^c	♦					♦
QoL assessment^d		♦	♦		♦	♦	♦
Blood test for translational study		♦				♦
Toxicity/compliance assessment			♦		♦	♦
Vital & progression status, late toxicity recovery							♦

^a3 cycles of 3 weekly DCF (docetaxel, cisplatin, 5FU) or 4 cycles of biweekly modified DCF
^bcomplete blood count, sodium, potassium, creatinine, bilirubin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, glucose, albumin, calcium, magnesium
^cfluorodeoxyglucose-positron emission tomography
^dEORTC-QLQ-C30 & development of a specific anal module by EORTC QoL group
Abbreviations: ECOG-PS, Eastern Cooperative Oncology Group-performance status; ECG, electrocardiogram; FDG-PET-CT, fluorodeoxyglucose-positron emission tomography–computed tomography; QoL, health-related quality of life

ISSN: 1471-2407