The first phase of the clinical trial aims to test and prove the feasibility and tolerability of the implantation of the magnetic liquid for esophageal cancer. The goal of the trial initially consists of dosage finding for the required amount of the magnetofluid to be applied and the strength of the magnetic field which is required for thermal excitation. After the definition of the maximum tolerated dosage of the applied magnetic field fluid, magnetic field strength, temperature and chemotherapeutic agent, a later Phase II trial is to examine the therapeutic response and the therapy-induced side effect rate. 

Study title

Feasibility trial on magnetic field hyperthermia in combination with radiochemotherapy for metastased esophageal carcinoma

Primary investigator

Prof. Dr. Beate Rau, Charité Campus Mitte, Clinic for General, Abdominal, Thoracic and Vascular Surgery  

Study start

March 2006

Inclusion criteria

• Plate epithelium and adenocarcinoma of the thoracic esophagus and the esophageal-gastric transition which can be considered for endoscopic and/or CT controlled magnetic fluid infiltration in terms of their spread
• uT2-T3, N0-2, M1, incurable
• Patient consent

Exclusion criteria

• Age > 75 years
• Karnofsky Index d 60%, WHO activity status d 2 
  
• Manifest pulmonary insufficiency (despite medication, paO2 < 55 mm Hg, FEV1 < 60%, vital capacity < 60%), florid pneumonia or bronchitis)
• Manifest cardiac insufficiency (despite therapy, cardiac insufficiency stage > II as per NYHA), unstable angina pectoris during stress or at rest, proven myocardial infarction within the past three months
• Manifest renal insufficiency (despite therapy, serum creatinine levels > 1.4 mg/dL, creatinine clearance d 60 mL/min)
• Manifest hepatic insufficiency (biopsy confirmed liver cirrhosis or fulfillment of two of the following criteria: Bilirubin > 2mg/dL, Quick < 70%, total protein < 3.5g/dL)
• Gastrointestinal bleeding
• Manifest neurological and psychiatric disturbances
• Insufficient bone marrow reserves (leukocytes < 4.0 G/L, thrombocytes < 100 G/L)
• Previous chemotherapy or radiation therapy in the thoracic region
• Metal parts in the chest, neck or upper abdomen (such as cardiac pacemaker, IV port with metal parts)
• Pregnancy, wants children
• Tumor fistula into the tracheobronchial tree