Electrochemotherapy for Chest Wall Recurrence af Breast Cancer: Present Challenges and Future Prospects.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Electrochemotherapy for Chest Wall Recurrence af Breast Cancer: Present Challenges and Future Prospects.|
- Clinical Measure of Lesion Size. [ Time Frame: up to one year ] [ Designated as safety issue: No ]Response was evaluated clinical using Response Evaluation Criteria in Solid Tumors (RECIST) guidelines and documented with digital photography. Number of patients with objective response evaluated with clinical measure of lesion size
- Participants With Objective Response Evaluated With PET/CT [ Time Frame: 3, weeks, 8 weeks, and up to 6 months after treatment ] [ Designated as safety issue: No ]Participants with objective response evaluated with PET/CT. Objective Response evaluated with CT and PET/CT.
- Safety and Toxicity [ Time Frame: up to 1 year ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2008|
|Study Completion Date:||December 2010|
|Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
Patients with local-regional recurrence of breast cancer, lesion over 3 cm.
Electric pulses , duration 100 microseconds, about 400 V given at 5000 Hz. Drug used is Bleomycin.
Electrochemotherapy for chest wall recurrence of breast cancer. MD, Ph.D. student, Louise Wichmann Matthiessen, has been employed in 2008 to perform this study. She plans to complete her training as specialist in clinical oncology subsequently, and will thus be able to follow up the work after completion of her Ph.D. The study aims at giving palliation to patients who are suffering from painful, ulcerated metastases to the chest wall in a situation where other treatments have failed.
Inclusion criteria: Chest wall recurrence of breast cancer; all other modalities have failed or patients does not wish to receive them (e.g. chemotherapy); symptomatic relief is needed; WHO performance status 0-2; normal coagulation parameters, normal kidney and renal function; written, informed consent. Lesions totalling over 3 cm in diameter. Patient recruitment: 28 patients are to be recruited.
Treatment: Patients will be treated in general anesthesia (inhaling max. 30 % oxygen), and a standard dose of bleomycin (15.000 IU/ m2) will be given intravenously. Electric pulses will be administered using a square wave electroporator (IGEA, Carpi, Italy). Needle and plate electrodes are used in order to treat the affected area efficiently. Eight pulses at a frequency of 5 kHz will be used for each application of the electrodes. In this way, a large area can be treated within a short time. Post treatment, the area will be covered by dry dressings, as are standardly used.
The patients will be seen at 2, 4, and 8 weeks post treatment, and re-treatment can be administered up to three times in case there are areas which have not been insufficiently treated in the first round. Lung function will be followed by measurement of DLCO (carbon monoxide diffusion capacity).
The patients will furthermore be followed up to 1 year after treatment in monthly intervals, and after 1 year on a yearly basis for up to 5 years.
Evaluation: Evaluation is performed by a) measurement of lesion extension and digital photography, b) development of a mapping system: Chest wall recurrences are frequently a confluent mass of tumor with varying depth. Precise mapping of treatment areas and effect is warranted. To this end, a system combining a fixed point (e.g. small ink tattoo, as used in radiotherapy planning) with novel imaging techniques using the 3D computer tomography (CT) planning system employed for radiotherapy, is envisaged. Furthermore, PET-Dual Time Point scanning combined with CT scanning is being investigated as treatment evaluation.
Safety: Safety will be reported both in terms of evaluation of adverse events and in terms of patient satisfaction determined by questionnaire, including the 'Derriford Appearance Questionaire'(18).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00744653
|Herlev Hospital, Herlev Ringvej 75|
|Herlev, Denmark, DK-2730|
|Principal Investigator:||Julie Gehl, M.D.||Department of Oncology, Copenhagen University Hospital at Herlev|