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Definitive Radiochemotherapy With 5-FU / Cisplatin Plus/Minus Cetuximab in Unresectable Locally Advanced Esophageal Cancer: a Phase II Study

Phase 2
18 Years
Open (Enrolling)
Esophageal Cancer

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Trial Information

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

2-year survival

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Dirk Rades, Prof. Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Klinik für Strahlentherapie


Germany: Paul-Ehrlich-Institut

Study ID:




Start Date:

September 2011

Completion Date:

Related Keywords:

  • Esophageal Cancer
  • non resectable
  • locally advanced
  • Cetuximab
  • radiation
  • Esophageal Diseases
  • Esophageal Neoplasms