A PHASE II STUDY WITH OXALIPLATIN + 5FU + CETUXIMAB AND RADIOTHERAPY FOR TREATMENT OF NON-RESECTABLE, LOCALLY ADVANCED BUT NOT METASTATIC CANCER OF OESOPHAGUS OR THE CARDIA REGION - LERFOX-C

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 90

Inclusion Criteria

•Histologically verified squamous cell carcinoma (including
basaloid-squamous cell and adenosquamous carcinoma) or
adenocarcinoma of the esophagus or the esophagogastric
junction (types I and II according to the Siewert
classification)
•Performance status (WHO) 0-2, age 18-80 y
•Locally advanced disease non-resectable (T4 N0-N3, M0) or disease which is not operable for any other reason (T2/T3 N0-N3, M0)
•Adequate hematological values: neutrophils = 1.5 x 109/L,
platelets = 100 x 109/L, Hb =9.0g/dL
- Adequate liver function:bilirubin = 1.5 x ULN, AP = 2.5 x
ULN, AST & ALT = 1.5 x ULN
- Adequate renal function: GFR > 60 mL/min or Serum
creatinine: = 100 mikromol/l
•Written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 55
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 35

Exclusion Criteria

•Distant metastases
•Prior chemotherapy or radiotherapy for oesophageal ca or ca of the cardia region
•Symptomatic peripheral neuropathy equal to or greater than NCI grade 2
•Other concomitant serious illness or medical condition that would not permit the patient to complete the study treatment or sign the informed concent
•? Severe or uncontrolled cardiovascular disease (congestive
heart failure NYHA III or IV), unstable angina pectoris,
history of myocardial infarction within the last 12 months,
significant arrhythmias)
? Active uncontrolled infection
? Serious underlying medical condition (judged by the
investigator) which could impair the ability of the patient to
participate in the trial (e.g. uncontrolled diabetes mellitus,
active autoimmune disease)
? Concurrent treatment with other experimental drugs or other
anti-cancer therapy; treatment in a clinical trial within 30
days prior to trial entry
? Definite contraindications for the use of corticosteroids and
antihistamines as premedication
? Known hypersensitivity to trial drugs or hypersensitivity to
any other component of the trial drugs
? Any concomitant drugs contraindicated for use with the trial
drugs according to the product information of the
pharmaceutical companies
•Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin) unless treated, in remission and off active treatment for greater than 5 years
•Pregnancy
- Breastfeeding women

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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