EUCTR2013-002647-29-ES
Active, not recruiting
Not Applicable
Clinical trial to evaluate the efficacy and tolerability of electrochemotherapy for palliative treatment in patients with head and neck squamous cell carcinoma
Fundació Clínic per a la Recerca Biomèdica0 sitesDecember 27, 2013
DrugsBleomicina Mylan
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Fundació Clínic per a la Recerca Biomèdica
- Status
- Active, not recruiting
- Last Updated
- 12 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Patients of both sexes and equal to or more than 18 years old
- •2\) Patients with one or more cutaneous or subcutaneous local or locoregional tumors as relapse or progression of squamous cell carcinoma of head and neck
- •3\) Patients with a tumor that does not invade the wall of the artery carotid with risk of rupture
- •4\) Patients whose target lesion is resistant to palliative chemotherapy and which cannot be applied palliative local treatments such as radiotherapy, surgery of scarce mutilation or first\-line systemic chemotherapy
- •5\) Patients with a expectation of life of 2\-3 months
- •6\) Patients with a degree of activity of the ECOG scale of 2 or less
- •7\) Patients who, properly informed, consent in writing to participate in the study and submit to the tests and procedures required by the study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
Exclusion Criteria
- •1\) Pregnancy or lactation during the study period
- •2\) Patients with allergy to Bleomycin
- •3\) Patients who have received the maximum dose of Bleomycin (400 mgm2\)
- •4\) Patients with previous pulmonary fibrosis or hemolytic uremic syndrome
- •5\) Use of drugs contraindicated in the study procedure
- •6\) Contraindication for the use of any of the drugs /products of the study
- •7\) Hypersensitivity to any components of the anesthesia used during the procedure
- •8\) Patients with creatinine\> 1\.5 values mgdL
- •9\) Patients with severe coagulopathy prior at the entry of the study
- •10\) Patients enrolled in other clinical trials at the same time
Outcomes
Primary Outcomes
Not specified
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