The primary objective of this study is to determine the response rate of electrochemotherapy in head and neck cancer. Secondary objectives are to monitor local and systemic side effects and adverse events and to determine quality of life before and…
ID
Source
Brief title
Condition
- Respiratory and mediastinal neoplasms malignant and unspecified
- Head and neck therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Treatment response
Secondary outcome
Adverse effects and serious adverse events and quality of life
Background summary
Na eerdere behandelingen in het hoofd-halsgebied kunnen bij de behandeling van
een nieuwe/recidu/recidief tumor geen reguliere therapeutische opties meer
voorhanden zijn. Electrochemotherapie is een relatief nieuwe
behandelingsmodaliteit die soms nog wel mogelijk is.
Study objective
The primary objective of this study is to determine the response rate of
electrochemotherapy in head and neck cancer. Secondary objectives are to
monitor local and systemic side effects and adverse events and to determine
quality of life before and after electrochemotherapy
Study design
Prospective, monocenter open-label study of 10 patients to define the treatment
response of electrochemotherapy in end-stage head and neck cancer patients.
Intervention
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.
Study burden and risks
Burden to the patient consist of hospital admission and treatment under general
anesthesia. Risks are related to reported adverse effects, e.g. pain, bleeding,
oedema and necrosis.
De Boelelaan 1117
1081 HV
NL
De Boelelaan 1117
1081 HV
NL
Listed location countries
Age
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 < 150 µmol/l
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL34661.029.10 |