Electrochemotherapy in head and neck cancer patients

Electrochemotherapy in head and neck cancer patients - Electrochemotherapy in head and neck cancer patients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON36446

Enrollment

Registered

2011-01-17

Start date

2011-05-01

Completion date

Unknown

Last updated

2024-12-02

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

Conditions

head and neck cancer

Interventions

Intratumoral or intraveneous application of bleomycin fllowed by electroporation in which an applicator with needle electrodes are repeatedly applied to the entire tumor with margins.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Biopsy confirmed malignancy of mucosa or skin Accessibility of the entire tumor (with 0.5 cm margins) for the applicator with electrode array all directions Creatinine level

Exclusion criteria

Exclusion criteria: Tumors that involve a 50% or greater encasement of a blood vessel as measured by MRI or CT scan Tumors having bone invasion Hypersensitivity to Bleomycin Subjects who have received or will exceed a total lifetime dose of Bleomycin greater than 400.000 IUg/m2 Subjects deemed unsuitable for general anesthesia and local anesthesia is not possible. Subjects with pulmonary fibrosis. Subjects with indwelling cardiac pacemakers who cannot tolerate a period with pacemaker turned off Subjects with a history of uncontrolled cardiac arrhythmia Women who are pregnant, or are nursing

Design outcomes

Primary

Measure	Time frame
Treatment response	—

Secondary

Measure	Time frame
Adverse effects and serious adverse events and quality of life	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)