Definitive Radiochemotherapy With 5-FU / Cisplatin Plus/Minus Cetuximab in Unresectable Locally Advanced Esophageal Cancer: a Phase II Study
Inclusion Criteria:
- Dated and signed written informed consent
- Male or female patients between 18 years and 75 years; patients > 75 years if their
karnofsky performance status is ≥ 80.
- Histologically proven squamous cell carcinoma or adenocarcinoma of the esophagus
which is not curatively resectable. Resectability has to be defined by a surgeon
before radiochemotherapy. The tumor is considered unresectable due to T-stage,
N-stage, performance status, nutritional status, co-morbidity (pulmonal function,
other), tumor location upper third or other reasons
- Karnofsky Performance Status ≥ 70
- Women of child-bearing potential must have a negative pregnancy test
- Adequate cardial-, pulmonal- and ear function
Adequate bone marrow function:
- leukocytes ≥ 3.0 x 10^9/L
- neutrophiles ≥ 1.5 x 10^9/L
- thrombocytes ≥ 100 x 10^9/L
- hemoglobin ≥ 10.0 g/dl
Adequate liver function:
- bilirubin ≤ 2.0 mg/dl
- SGOT, SGPT, AP, gamma-GT ≤ 3 x ULN
Adequate kidney function:
- serum creatinine ≤ 1.5 mg/dl
- creatinine clearance ≥ 50 ml/min according to Cockcroft-Gault Formula
- no known allergies against chimeric antibodies
- effective contraception for male and female patients if there is a risk of conception
Exclusion Criteria:
- distant metastasis
- previous treatment of esophageal cancer
- previous therapy with monoclonal antibodies and / or EGFR-targeted therapy
- previous second malignancies with exception of a history of a previous curatively
treated basal cell carcinoma of the skin or pre-invasive cervix carcinoma
- serious concomitant disease or medical condition
- FEV1 < 1.1
- clinically relevant coronary artery diseases or known myocardial infarction within
the last 12 months or ventricular ejection fraction (LVEF) below normal
- every active dermatological condition > grade 1
- contraindications to receive cisplatin, 5-FU or cetuximab
- concurrent treatment with other experimental drugs or participation in another
clinical trial within 30 days before study start
- patient pregnant or breast feeding
- known drug abuse, medication abuse, alcohol abuse
- social situations limiting the compliance with the study requirements