Esophageal cancer MedDRA version: 21.0 Level: LLT Classification code 10015362 Term: Esophageal cancer System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Calciumgluconat "B. Braun"
Pharmaceutical Form: Injection
INN or Proposed INN: CALCIUM GLUCONATE
Other descriptive name: CALCIUM GLUCONATE
Concentration unit: mmol/ml millimole(s)/millilit
Sponsors
Michael Patrick
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female =18 years old. 2. Histological verified malignant tumor in the esophagus, including the GEJ. 3. Subjects must have been evaluated by an MDT and been considered unsuitable for potential curative treatment. 4. Locally progressive disease, and other standard oncological treatment have been considered. 5. Performance status ECOG/WHO 3 months. 7. Platelets = 50 billion/l, International Normalized Ratio (INR) =65 years) yes F.1.3.1 Number of subjects for this age range 4
Exclusion criteria
Exclusion criteria: 1. Coagulation disorder that cannot be corrected. 2. Subjects with a clinically significant cardiac arrhythmia. 3. Pregnancy or lactation. 4. Concurrent treatment with another investigational medicinal product. 5. Stenosis that prevents passage of the endoscope with the device attached. 6. Patients with any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the study requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the safety of CaEP for esophageal cancer. Adverse Events (AE) and Serious Adverse Events (SAE) will be evaluated.;Secondary Objective: Evaluate treatment response. ;Primary end point(s): Safety of CaEP for esophageal cancer, measured by registering Adverse Events (AE) and Serious Adverse Events (SAE). ;Timepoint(s) of evaluation of this end point: At follow up visits within 14 days after the given treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: At follow up visits within 2 months after the given treatment. ;Secondary end point(s): Secondary outcomes include: - dysphagia (Mellow Pinkas dysphagia score) - pain (Numeric Rating Scale, NRS) - quality of life (QoL) (EORTC QLQ-C30) - tumor response evaluated from computed tomography (CT) and upper endoscopy - immunologic response | — |
Countries
Denmark
Contacts
Public ContactCharlotte Egeland
Charlotte Egeland
Outcome results
None listed