Last updated on August 2018

Study of the Interest of Pursuing or Not the Chemotherapy for Patients With Metastatic Esophageal Cancer

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Squamous Cell | Esophageal Cancer
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

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

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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