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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02549742 |
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Date of registration:
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06/09/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Electrochemotherapy on Head and Neck Cancer
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Scientific title:
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Electrochemotherapy on Head and Neck Cancer |
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Date of first enrolment:
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February 2014 |
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Target sample size:
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25 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02549742 |
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Study type:
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Interventional |
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Study design:
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Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Christina C. Plaschke, MD |
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Address:
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Telephone:
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+45 29 25 92 45 |
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Email:
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caroline@dadlnet.dk |
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Affiliation:
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Name:
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Christina C. Plaschke, MD |
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Address:
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Telephone:
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+45 29 25 92 45 |
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Email:
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caroline@dadlnet.dk |
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Affiliation:
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Name:
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Julie Gehl, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Denmark: Herlev and Gentofte Hospital, University of Copenhagen |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Subject age > 18 years.
2. Verified cancer of the head and neck area of any histology.
3. At least one tumour lesion should be accessible for electroporation.
4. Performance status WHO <= 2nd
5. Progressive and / or metastatic disease.
6. Expected survival of > 3 months.
7. Measurable disease is defined as at least one measurable lesion by RECIST 1.1.
8. A treatment-free interval of more than 4 weeks since chemotherapy or radiation
therapy.
9. The participant should have been offered the current standard treatment. If there are
no further standard treatment to offer or if the participant does not want to receive
this, the participant may be included in the trial.
10. The participant should be able to understand the information for participants and be
willing and able to comply with hospitalization in the treatment and the agreed
follow-up visits and tests.
11. Platelets = 50 billion / L, INR (international normalized ratio) > 1.5. Medical
correction is permitted, e.g. correction using vitamin K.
12. Sexually active women who can become pregnant should use adequate contraception during
this trial and 6 months after administration of bleomycin (pill, spiral, injection of
prolonged progestin subdermal implantation, hormone-containing vaginal devices,
transdermal patches).
13. Signed informed consent. -
Exclusion Criteria:
Participants should be excluded if they meet just one of the criteria stated below.
1. Symptomatic progression of the participants cancerous disease that requires another
intervention.
2. Acute lung infection
3. Symptoms of lung function impairment. This triggers a lung function test (DLCO =
diffusing capacity of the lungs for carbon monoxide), if moderate to severe the
participant will be excluded.
4. Previous bleomycin treatment with cumulative dose more than 240,000 Units / m2.
5. History of severe allergic reactions associated with bleomycin.
6. Allergy to constituents of the planned anesthetic.
7. Coagulation disorder which can not be corrected.
8. Chronic renal dysfunction with creatinine> 150 micromoles / liter, will trigger a
Cr-51-EDTA (Chromium-51-ethylenediamine tetra acetic acid) clearance. If this is too
impaired, the participant is excluded.
9. Pregnancy or lactation.
10. While participation in other clinical trials involving experimental drugs or involved
in a trial within 4 weeks prior to study drug administration.
11. Other disorders investigator finds incompatible with participation in the trial. -
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Head Neck Cancer
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Intervention(s)
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Drug: Bleomycin
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Device: Cliniporator
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Procedure: Electrochemotherapy
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Primary Outcome(s)
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Tumour response from PET/CT scans (Positron Emission Tomography - Computed Tomography)
[Time Frame: 8 weeks after treatment]
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Secondary Outcome(s)
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Tumour response from MRI scans (Magnetic resonance imaging)
[Time Frame: 8 weeks after treatment]
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VAS score (Visual Analogue Scale)
[Time Frame: baseline, 4 weeks and 8 weeks after treatment]
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Tumour response from tissue samples
[Time Frame: 4 weeks after treatment]
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CTCAE recordings (Common Terminology Criteria for Adverse Events)
[Time Frame: baseline, 4 weeks and 8 weeks after treatment]
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Quality of life
[Time Frame: baseline, 4 weeks and 8 weeks after treatment]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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