Endoscopic Assisted Electrochemotherapy in Addition to Neoadjuvant Treatment of Locally Advanced Rectal Cancer

• Status: Unknown status
• Trial end date: 2019-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of neoadjuvant electrochemotherapy on locally advanced rectal cancer (UICC II-III) in an intended curative clinical setting, using an endoscopic electroporation device (EndoVE).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zealand University Hospital
• Collaborators: Herlev Hospital; Rigshospitalet, Denmark
• Treatments: Bleomycin

Criteria

Inclusion Criteria:

1. Patient must be mentally capable of understanding the information given.

2. Patients must give written informed consent.

3. Men or women aged at least 18 years.

4. Histologically verified rectal tumor (adenocarcinoma)

5. Case reviewed by MDT (surgery, radiology, oncology). Case considered curable with neoadjuvant therapy followed by surgical excision (UICC stadium II-III).

6. ASA class I-III (Classification of the American Society of Anesthesiology)

Exclusion Criteria:

1. Coagulation disorders

2. Highly inflamed gastrointestinal tissue which is ulcerated and bleeding

3. Patients with ICD or pacemaker units.

4. Patients with epilepsy.

5. Pregnancy or lactation/breastfeeding.

6. Patients with known Hepatitis B/C or HIV infection.

7. Patients who have undergone treatment with bevacizumab within 4 weeks prior to enrolment in this trial.

8. Patients with concomitant use of phenytoin.

9. Patients with concomitant use of clozapine.

10. Concurrent treatment with an investigational medicinal product.

11. 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 recruitments.

12. Patients with contraindications for PET/MRI scan:

13. Advanced tumor stage, UICC stage IV.

14. Acute pulmonary infection.

15. Medical history of severe pulmonary disease.

16. Previous allergic reactions to bleomycin.

17. Previous cumulative dose of bleomycin exceeding 250.000 IU/m2.

18. Pre-existing renal dysfunction. Creatinine clearance < 40 ml/min.

19. Platelet count ≤50 mia/l.

20. Prothrombin time ≥ 40 sec

21. Patients registered in the Danish Tissue Register (Vaevsanvendelsesregistret)