Clinical trial NCT00160030 (phase 2, status: completed)
Conditions: esophageal neoplasms
ICD codes: K22.2, K22.81, Q39.4, P78.83, I85.00, I85.01, I85.10
Drugs: folfox 4, 5-fu / cisplatin
SMILES: [H][N]([H])([H])[Pt](Cl)(Cl)[N]([H])([H])[H]
Eligibility criteria:

        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.