Chemotherapy breakthrough? study cut short for esophageal cancer patients

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients suffering from squamous-cell type esophageal cancer histologically proved * Metastatic disease measurable according to RECIST criteria. Patients with metachronous metastasis and who have been treated with surgery (+/- radio chemotherapy concurrent or adjuvant chemotherapy) or exclusive radio chemotherapy, are eligible * Patients who show progress under chemotherapy that associates a fluoropyrimidine with a platinum salt * Man or woman over 18 years old * ECOG performance status ≤ 2 * Adequate haematological, renal and hepatic functions : PNN ≥ 1500/ mm3; platelets ≥ 100 000/ mm3; Haemoglobin ≥ 9.0 g/dL; ALT and AST ≤ 2.5 ULN (≤ 5.0 in case of liver metastases); Total bilirubin ≤ 1.5 X ULN; Serum creatinine ≤ 1.5 ULN * Efficient contraceptive method for both gender (if applicable), during the whole treatment period and the 6 months following the last treatment administration * Affiliation to the National Social Security System * With informed and signed consent Inclusion Criteria for randomization: * ECOG performance status ≤ 2 * Able to pursuit the LV5FU2-paclitaxel chemotherapy * Non-progressive disease after the initial phase (first tumor exam at week 6) Exclusion Criteria: * Patients who received more than one line of chemotherapy for a metastatic disease * Presence of other evolutive tumors * Cerebral metastasis or other known brain tumors * Severe liver failure * Pernicious anemia or other anemia due to vitamin B12 defficiency * Hypersensibility to an active substance or any other excipients of experimental drugs * Every unstable chronicle diseases that can affect patient confidence or security * Clinically significant active cardiac disease or myocardial infarction in the 6 previous months * Patients with a known dihydropyrimidine dehydrogenase (DPD) deficiency * Concomitant treatment with : sorivudin or analogs; prophylactic phenytoin * Live attenuated vaccine within the 3 previous months * Pregnant or breastfeeding women * Unable to comply with the medical monitoring for geographic, social or mental issues * Patient Under guardianship or tutorship