Patients with histologically verified inoperable, locally advanced but non metastastic oesophageal ca or the ca of cardia region
Conditions
Interventions
Trade Name: Erbitux
Product Name: Erbitux
Pharmaceutical Form:
Sponsors
Karolinska University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determine local tumour control at 1 year ;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 | — |
Countries
Denmark, Norway, Sweden
Outcome results
None listed