Table 1 Inclusion and exclusion criteria of the trial

Inclusion criteria

➢ Histologically proved, and unresectable locally advanced recurrent or metastatic SCCA patient

➢ Eligible for DCF or mDCF regimen

➢ Age ≥ 18 years

➢ ECOG-PS of 0 or 1

➢ Signed written informed consent

Exclusion Criteria:

➢ Known hypersensitivity or contraindication to any of the study drugs (docetaxel, cisplatin, 5-fluorouracil).

➢ Previous chemotherapy for metastatic disease

➢ Previous chemotherapy by paclitaxel, docetaxel or navelbine

➢ Previous chemotherapy by cisplatin, except of concomitant radiotherapy

➢ HIV positive patient with lymphocyte CD4 count under 400/mm³

➢ Concomitant treatment with a CYP3A4 inhibitor*

➢ Inadequate organ function

➢ Other malignancy within the last 3 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer.

➢ Simultaneous participation in another clinical study

➢ Pregnancy, breast-feeding or absence of adequate contraception for fertile patients

➢ Patients with any disabling medical or psychiatric condition or disease for this study.

➢ Presence of peripheral neuropathy

➢ Presence of auditory disorders

➢ Yellow fever vaccination, prophylactic use of phenytoin, live-attenuated vaccines

➢ Inadequate bone marrow, renal and liver function

○ Neutrophil count <1500/mm³,

○ Platelet count <100,000/mm³,

○ Clearance of creatinine (Cockcroft formulae) < 60 ml/min,

○ AST and ALT >2.5 × upper limit of normal (> 5 x upper limit of normal in case of known liver metastases)

○ Total bilirubin >2.5 × upper limit of normal

* The treatment can be replaced or stopped before inclusion