Medpulser Electroporation With Bleomycin Study to Treat Anterior Head and Neck Squamous Cell Carc… (NCT00198315) | Clinical Trial Compass
TerminatedPhase 3
Medpulser Electroporation With Bleomycin Study to Treat Anterior Head and Neck Squamous Cell Carcinoma
Stopped: Enrollment was stopped based on the Data Monitoring Committee's recommendation.
United States130 participantsStarted 2004-06
Plain-language summary
The purpose of the study is to evaluate Medpulser electroporation (EPT) with bleomycin with regard to local tumor recurrence, disease-free survival, and overall survival rates versus surgery in recurrent or secondary primary squamous cell carcinoma (SCC) of the anterior oral cavity, soft palate, or tonsil.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. The presence of SCC of the anterior oral cavity, soft palate or tonsil must be confirmed by histological examination of a tissue sample (e.g., biopsy) obtained within 1 month of the patient receiving the study treatment.
. Recurrent or second primary disease in patients where surgical resection is seen as an option for disease control.
. The length of the longest diameter of the study lesion must be \< 5 cm and the calculated treatment volume must be \< 60.0 cm3 (tumor volume plus a 0.5 cm margin around the tumor) for the study lesion \[where treatment volume = 0.5 (A+1) (B+1)2 and where A = length of the longest diameter (cm), B = the next longest diameter perpendicular to "A" (cm)\].
. Tumor burden must be completely encompassed by surgery or bleomycin-EPT.
. Age: 18 years or older.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Function status at 4 months using the performance status scale for head and neck cancer (PSSHN) and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Head and Neck (EORTC-QLC-H&N35)
. Men and women of childbearing potential must use physician approved contraceptive methods for 7 days following bleomycin-EPT.
. Hematopoietic status:
. Blood chemistry status:
Exclusion criteria
. Patients with tumors suspected of involving a 50% or greater encasement of a blood vessel as measured by magnetic resonance imaging (MRI) or computed tomography (CT) scan.
. Patients with tumors having bone invasion.
. Patients with any metallic implants in the treatment field.
. Patients with hypersensitivity to bleomycin.
. Patients who have received or will exceed a total lifetime dose of bleomycin greater than 400 units.
. Patients deemed unsuitable for general anesthesia.
. Patients with a significant history of emphysema or pulmonary fibrosis.
. Patients with indwelling cardiac pacemakers who cannot tolerate a period with pacemaker turned off.