Esophageal cancer MedDRA version: 21.0 Level: LLT Classification code 10015362 Term: Esophageal cancer System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Bleomycin
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: BLEOMYCIN
CAS Number: 11056-06-7
Concentration unit: IU international unit(s)
Concentrati
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. Subjects must not have received any previous oncological treatment due to this current cancer. 5. Performance status ECOG/WHO 3 months. 7. Platelets = 50 billion/l, International Normalized Ratio (INR) 40 mL/min) are excluded. (Se-creatinine > 150 ?mole/l triggers a Cr-51-EDTA-clearence test). 9. Subjects must be willing and able to comply with the procedure such as agreed follow-up visits. 10. Sexually active women who can become pregnant should use adequate contraception during the trial (pill, spiral, injection of prolonged progestin, sub dermal implantation, hormone-containing vaginal devices, transdermal patches). 11. Subjects must give written informed consent. 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 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: 1. Coagulation disorder that cannot be corrected. 2. Subjects with renal dysfunction (Cr-51-EDTA-clearance 240.000 UI/m2. 8. Stenosis that prevents passage of the endoscope with the device attached. 9. 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: Investigating if a single treatment with electrochemotherapy debulks an esophageal tumors, thereby facilitating the patients’ ability to eat and drink, and also prolongs the interval before definitive stenting is required. Further investigate weather the effect lasts longer than the effect from argon plasma coagulation. ;Secondary Objective: N/A ;Primary end point(s): Difference in Time-to-Interventional-Treatment-Demanding-stricture-related-Dysphagia (TITDD) between patients treated with electrochemotherapy and patients treated with argon plasma coagulation.;Timepoint(s) of evaluation of this end point: It is registred when appearing or followed until death, maximum 2 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary outcomes include: ? dysphagia (Mellow Pinkas dysphagia score) ? pain (Visual Analog Scale, VAS) ? quality of life (QoL) (EORTC QLQ-C30) ? Adverse events (AEs) and Adverse reactions (ARs) ? tumor response evaluated from computed tomography (CT) ? tumor response evaluated from upper endoscopic exams ? 90 days survival ? 1 year survival ;Timepoint(s) of evaluation of this end point: At day 7, months 1 and 3, and after 1 year. | — |
Countries
Denmark
Contacts
Public ContactCharlotte Egeland
Charlotte Egeland
Outcome results
None listed