Clinical trial NCT00160030: Study Comparing Radiochemotherapy With Folfox 4 Regimen or 5FU-Cisplatin in Patients With Inoperable Esophageal Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Esophageal Neoplasms
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objectives of this study are to assess the feasibility (completion of full treatment) in both arms and to assess endoscopic complete response rate in both arms.

The secondary objective of this study is to assess the toxicity profile of each arm using the National Cancer Institute-Common Toxicity Criteria (NCI-CTC) scale (V.3).


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.

Primary outcomes:
measure: Percentage of patients having completed the full treatment and Endoscopic complete response rate
timeFrame: at the end of the study
Secondary outcomes:
measure: Toxicity profile (NCI-CTC).
timeFrame: evaluated each week
Other outcomes:
Locations:
city: Paris
country: France
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: Marie SEBILLE
role: STUDY_DIRECTOR
References: