Study Comparing Radiochemotherapy With Folfox 4 Regimen or 5FU-Cisplatin in Patients With Inoperable Esophageal Cancer

Inclusion Criteria:

Patients with:

* Histologically proven adenocarcinoma, squamous cell or adenosquamous carcinoma of the esophagus
* Inoperable esophageal carcinoma (disease status: any T, N0 or N1, M0 or M1a) or surgical contraindication conditions
* No prior treatment for esophageal cancer (surgery, laser, chemo- or radiotherapy)
* Oesophageal dilatation is allowed before or during the treatment, but prior esophageal prosthesis is not allowed
* Peripheral neuropathy \<= NCI-CTC grade 1
* Age \>= 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) \<= 2
* Sufficient (oral or with gastrostomy) calorific intake (\> 1000 Kcal/m2/day)
* Life expectancy \>= 3 months
* Adequate bone marrow reserve, normal renal and liver functions:

  * Neutrophil count \>= 1500/mm³
  * Platelet count \>= 100,000/mm³
  * Hemoglobin \>= 10 g/dl (after transfusion, if necessary)
  * Creatinine levels \<= 1.5 x the upper normal limit of institutional values (ULN)
  * Total bilirubin level \< 1.5 x ULN
  * ALT/AST \< 2.5 x ULN
  * Prothrombin time \>= 60%
* Laboratory values obtained the week preceding study entry
* Signed informed consent (prior to all study procedures)
* Start of treatment within 28 days of inclusion.

Exclusion Criteria:

* Metastatic disease except for third upper or cervical esophagus tumor with regional nodes, or third lower esophagus tumor with celiac nodes (M1a)
* Multiple carcinomas of the esophagus
* Small cell or undifferentiated carcinoma of the esophagus
* Complete dysphagia (grade 4 NCI-CTC); patient with exclusive parenteral nutrition.
* Weight loss \> 20% normal body weight
* Pregnant or breast-feeding women
* Fertile patient not using adequate contraception
* Peripheral sensitive neuropathy with functional impairment
* Auditory disorders
* History of prior malignancies (other than cured non melanoma skin cancer, cured cervical carcinoma in situ or stage I or II node negative head and neck cancer cured \> 3 years ago)
* Prior cervical, thoracic and abdominal radiotherapy with field overlapping the proposed oesophageal radiotherapy field
* Tracheo-oesophageal fistula or invasion of the tracheo-bronchial tree
* Previous myocardial infarction (inferior or equal to 6 months). Patients with a previous myocardial infarction superior to 6 months, could be included only if: no transient ischemia is shown by thallium myocardial scintigraphy and favourable advice for chemotherapy is obtained from a cardiologist.
* Other serious illness or medical conditions (such as symptomatic coronary disease, left ventricular failure or uncontrolled infection)
* Arterial disease stage II to IV according to the Leriche and Fontaine classification
* Treatment with any other experimental drugs or participation in another clinical trial within 30 days of study screening
* Concurrent treatment with any other anti-cancer therapy
* Concurrent treatment with phenytoin and yellow fever vaccine; geographical, social or psychological circumstances preventing regular follow-up.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.