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 range18 Years
SexALL
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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.
✓. 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.
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)