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

Conditions: Patients with histologically verified inoperable, locally advanced but non metastastic oesophageal ca or the ca of cardia region

Registration Number: EUCTR2008-006802-40-SE

Lead Sponsor: Karolinska University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 90

Inclusion Criteria

•Histologically verified squamous cell carcinoma or adenocarcinoma of the oesophagus or cardia (Siewert I-II)
•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, liver and renal function
•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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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
•Myocardial infarction within 6 months prior to study entry
•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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Determine local tumour control at 1 year<br><br>;Secondary Objective: To analyse progression free survival, toxicity, pattern of relapse, resectability rate, overall and disease-free survival;Primary end point(s): To determine local tumour control at 1 year<br><br>

Secondary Outcome Measures