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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

Phase 2
18 Years
Not Enrolling
Esophageal Neoplasms

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Trial Information

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

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percentage of patients having completed the full treatment and Endoscopic complete response rate

Outcome Time Frame:

at the end of the study

Safety Issue:


Principal Investigator


Investigator Role:

Study Director

Investigator Affiliation:



France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

September 2004

Completion Date:

Related Keywords:

  • Esophageal Neoplasms
  • Neoplasms
  • Esophageal Diseases
  • Esophageal Neoplasms