Esophageal cancer MedDRA version: 19.0 Level: LLT Classification code 10056267 Term: Gastroesophageal cancer System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Bleomycin, "Baxter"
Product Name: Bleomycin
Pharmaceutical Form: Powder for concentrate for solution for injection/infusion
INN or Proposed INN: BLEOMYCIN
CAS Number: 11056-06-7
Concentrat
Sponsors
Michael Patrick Achiam
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female =18 years old. 2. Histological verified adenocarcinoma in the gastro-oesophageal junction. 3. Expected survival > 3 months. 4. Performance status ECOG/WHO 40 ml/min) are excluded. (Se-creatinine > 150 mole/L triggers a Cr-51-EDTA-clearence test). 8. Subjects must be willing and able to comply with the procedure such as agreed follow-up visits. 9. Subjects must give written informed consent. 10. The patient has a progressing disease, despite previously treatment with palliative chemo/radio therapy OR 11. The patient has a progressing disease, despite previously treatment with palliative radio therapy and he/she can not tolerate palliative systemic chemotherapy treatment. 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 4 F.1.3 Elderly (>=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 renal dysfunction (Cr-51-EDTA-clearance 150 micromole/L triggers a Cr-51-EDTA-clearence test). 3. Subjects with a clinically significant cardiac arrhythmia. 4. Diabetes. 5. Pregnancy or lactation/breastfeeding. 6. Concurrent treatment with an investigational medicinal product. 7. Contraindications for use of bleomycin, including acute pulmonary infection, severe pulmonary disease and allergic reactions to bleomycin observed in previous treatment. 8. Subjects who have previously undergone a regime of bleomycin with a cumulative dose of > 240.000 units/m2. 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. This includes stenosis that prevents passage of the endoscope.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Evaluation of tumour regression/reduction in volume measured via PET-MRI. Evaluation of the participants subject experience via life of quality questionaries and dysphagia score. ;Timepoint(s) of evaluation of this end point: PET-MRI at 4 and 8 weeks after initial treatment. Evaluation of the participants subject experience via life of quality questionaries and dysphagia score, day 7, week 4, week 8. | — |
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: All participants will have 3 schedualed follow up appointments. 7 days: Life of quality questionaries and dysphagia score. 1 months: Life of quality questionaries and dysphagia score + PET-MRI 2 months: Life of quality questionaries and dysphagia score + PET-MRI All participants will be followed for at least 2 months. ;Main Objective: The primary objectives of this phase I trial are to investigate the safety and side effects of treating patients with inoperable GEJ cancer with electroporation delivered through an endoscopic system. ;Secondary Objective: The secondary outcome is an evaluation of the response measured by: • Positron emission tomography–magnetic resonance imaging (PET-MRI) • Dysphagia by Mellow and Pinka’s dysphagia score • Patient experience of treatment by Quality of life questionnaires, EORTC QLQ-C30. ;Primary end point(s): Evaluation of safety and feasibility of this new method. | — |
Countries
Denmark
Contacts
Public ContactRigshospitalet
Department of Surgical Gastroenterology
Outcome results
None listed