Unresectable locally advanced esophageal cancer MedDRA version: 19.1 Level: LLT Classification code 10015362 Term: Esophageal cancer System Organ Class: 100000004864 MedDRA version: 19.1 Level: LLT Classification code 10030151 Term: Oesophageal cancer System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Erbitux
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Cetuximab
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5-
Sponsors
University Hospital Schleswig-Holstein, Campus Luebeck
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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 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
Exclusion criteria
Exclusion criteria: • 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 2-year overall survival ;Secondary Objective: 1-year overall survival 1-year and 2-year progression-free survival 1-year and 2-year loco-regional control 1-year and 2-year metastases-free survival Toxicity (NCI-CTC 4.0) Overall response rate (RECIST Version 1.1) Quality of Life (EORTC QLQ-C30 and QLQ OES18) In addition the following parameters will be assessed irrespective of a specific time point: • OS • PFS • MFS ;Primary end point(s): 2-year overall survival (rate);Timepoint(s) of evaluation of this end point: 2 years after start of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): [1] 1-year OS (rate) [2]-year and 2-year PFS (rate) [3] 1-year and 2-year LC (rate) [41] 1-year and 2-year MFS (rate) [5] OS, PFS, MFS Overall response rate Toxicity ;Timepoint(s) of evaluation of this end point: [1-4] 1 and 2 years after start of treatment, respectively [5] irrespective of a specific time point until 2 years after start of treatment of last patient Response rate and toxicity up to end of treatment evaluation (i.e. 16 weeks) | — |
Countries
Germany
Outcome results
None listed