Registry to collect clinical data on the effect and symptom control of electrochemotherapy for head and neck tumors

Recruiting

• Conditions: Malignant neoplasm of the oral cavity, oropharynx, hypopharynx, larynxrecurrent, metastatic or primary cancer of the head and neck (histology of any type); C14.8; C10.8; C32.8; C13.8; D23.9; Overlapping lesion of lip, oral cavity and pharynx; Overlapping lesion of oropharynx; Overlapping lesion of larynx; Overlapping lesion of hypopharynx

• Registration Number: DRKS00034205
• Lead Sponsor: niversitätsklinikum Jena, Klinik für Hals-, Nasen- und Ohrenheilkunde

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-07
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

? Histologically confirmed malignant neoplasm of any kind
? Progressive and / or metastatic disease or
? Primary disease that is not suitable for surgery due to the patient's general condition or the need for a very extensive surgical procedure or
? Patient refuses standard treatments or provides written informed consent. Inclusion is possible if the patient refuses another form of standard treatment. Patient gives written consent for treatment with electrochemotherapy.
? Measurable lesions that are suitable for the application of electrical impulses
? Treatment-free interval of at least 4 weeks after previous chemotherapy or radiotherapy of the target lesions
? Patients must be mentally capable of understanding the information and signing the consent form

Exclusion Criteria

? Patients with symptomatic or rapidly progressive metastases outside the ENT area
? Presence of lesions that are not indicated for treatment with ECT (bony infiltration, infiltration of large vessels, etc.)
? Acute pneumonia
? Pulmonary dysfunction
? Unrecoverable severe coagulation disorders
? Previous allergic reactions to bleomycin
? Cumulative dose of 240,000 IU BLM/m² was previously exceeded
? Chronic renal dysfunction (creatinine > 150 µmol/L)
? Pregnancy or breastfeeding

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of tumor response (of a target lesion) after electrochemotherapy treatment

Secondary Outcome Measures

Name	Time	Method
Safety (toxicity) of the procedure <br>Analysis of overall survival and progression-free survival