Definitive radiochemotherapy with 5-FU / cisplatin plus/minuscetuximab in unresectable locally advanced esophageal cancer
- Conditions
- nresectable locally advanced esophageal cancerMedDRA version: 19.1Level: LLTClassification code 10015362Term: Esophageal cancerSystem Organ Class: 100000004864MedDRA version: 19.1Level: LLTClassification code 10030151Term: Oesophageal cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2010-023427-18-DE
- Lead Sponsor
- niversity Hospital Schleswig-Holstein, Campus Luebeck
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 78
•Signed written informed consent
•Male or female between 18 and 75 years; patients > 75 years if KPS = 80
•Histologically proven squamous cell carcinoma or adenocarcinoma of the esophagus, which is not curatively resectable
•KPS = 70
•Women of child-bearing potential must have a negative pregnancy test
•Adequate cardiac, pulmonary, and ear function
•Adequate bone marrow function: leucocytes > 3.0 x 109/L, neutrophils > 1.5 x 109/L, platelets > 100 x 109/L, hemoglobin > 10.0 g/dL
•Adequate liver function: Bilirubin < 2.0 mg/dL, SGOT, SGPT, AP, ?-GT < 3 x ULN
•Adequate renal function: serum creatinine < 1.5 mg/dL, creatinine clearance > 50 ml/min (calculated value according to Cockroft-Gault equation)
•No known allergy against chimeric antibodies
•Effective contraception for both male and female patients if the risk of conception exists
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
•Distant metastasis (M1b)
•Previous treatment of esophageal cancer
•Previous exposure to monoclonal antibodies and / or EGFR-targeted therapy
•Other previous malignancy with exception of a history of a previous curatively treated basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
•Serious concomitant disease or medical condition
•FEV1 < 1,1
•Clinically relevant coronary artery disease or a history of myocardial infarction within the last 12 months or left ventricular ejection fraction (LVEF) below the institutional range of normal
•Any 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 with any investigational drug within 30 days prior to study screening
•Pregnancy or lactation
•Known active drug abuse/alcohol abuse
•Social situations limiting the compliance with the study requirements
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 2-year overall survival ;Secondary Objective: 1-year overall survival<br>1-year and 2-year progression-free survival <br>1-year and 2-year loco-regional control <br>1-year and 2-year metastases-free survival <br>Toxicity (NCI-CTC 4.0)<br>Overall response rate (RECIST Version 1.1)<br>Quality of Life (EORTC QLQ-C30 and QLQ OES18)<br><br>In addition the following parameters will be assessed irrespective of a specific time point: <br>•OS<br>•PFS<br>•MFS<br>;Primary end point(s): 2-year overall survival (rate);Timepoint(s) of evaluation of this end point: 2 years after start of treatment
- Secondary Outcome Measures
Name Time Method Secondary end point(s): [1] 1-year OS (rate)<br>[2]-year and 2-year PFS (rate)<br>[3] 1-year and 2-year LC (rate)<br>[41] 1-year and 2-year MFS (rate)<br>[5] OS, PFS, MFS<br><br>Overall response rate <br>Toxicity<br>;Timepoint(s) of evaluation of this end point: [1-4] 1 and 2 years after start of treatment, respectively<br>[5] irrespective of a specific time point until 2 years after start of treatment of last patient<br><br>Response rate and toxicity up to end of treatment evaluation (i.e. 16 weeks)