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.