Definitive Radiochemotherapy Plus/Minus Cetuximab in Unresectable Locally Advanced Esophageal Cancer
Conditions
Esophageal Cancer
Conditions: official terms
Esophageal Neoplasms
Conditions: Keywords
non resectable, locally advanced, Cetuximab, radiation
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Cetuximab Type: Drug
Name: Cisplatin, 5-FU Type: Drug
Name: Radiotherapy Type: Radiation
Overall Status
Recruiting
Summary
Esophageal cancer is a highly aggressive tumor. Treatment options are various and range from chemotherapy to radiotherapy and several surgical techniques. Nevertheless, the overall survival rates for this disease remain poor.

During the last years the combination of cetuximab with standard chemotherapy or radiotherapy has mainly be investigated in clinical trials focusing on colorectal and/or head and neck cancer.

The results obtained from theses studies were very encouraging and led to the initiation of active clinical research in esophageal cancer patients with antibody inhibition of the EGFR.

The first data in this indication are encouraging showing that cetuximab can safely be added to chemoradiation for esophageal cancer patients with first hints of efficacy.

Based on the experiences with cetuximab in colorectal cancer and in combination with radiotherapy in head and neck cancer, the aim of the present study is to evaluate the feasibility of a combined treatment of cetuximab with continuous infusional 5-FU, cisplatin and radiotherapy in patients with esophageal cancer and to assess if the overall survival rates can be increased by addition of an EGFR-targeted therapy.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Location
Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Klinik für Strahlentherapie
Lübeck, Germany
Status: Recruiting
Contact: Dirk Rades, Prof. Dr. - 0049 451 500-6660 - dirk.rades@uksh.de
Start Date
September 2011
Sponsors
University of Schleswig-Holstein
Source
University of Schleswig-Holstein
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page