Phase II Study Comparing Radiochemotherapy With the Folfox 4 Regimen Versus Radiochemotherapy With 5FU-Cisplatin (Herskovic Regimen) in First Line Treatment of 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.