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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00034205

Enrollment

150

Registered

2024-05-07

Start date

2021-09-14

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant neoplasm of the oral cavity, oropharynx, hypopharynx, larynx recurrent, metastatic or primary cancer of the head and neck (histology of any type) C14.8 C10.8 C32.8 C13.8 D23.9

Interventions

Group 1: Patients affected by recurrent ENT cancer (any type of histology) and/or metastatic ENT cancer or primary ENT cancer (any type of histology)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Evaluation of tumor response (of a target lesion) after electrochemotherapy treatment	—

Secondary

Measure	Time frame
Safety (toxicity) of the procedure Analysis of overall survival and progression-free survival	—

Countries

Germany

Contacts

Public ContactGerlind Schneider

Universitätsklinikum Jena, Klinik für Hals-, Nasen- und Ohrenheilkunde

HNO-Studienbuero@med.uni-jena.de+4936419329354

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 11, 2026