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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT00440934 |
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Date of registration:
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24/02/2007 |
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Primary sponsor: |
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Public title:
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A Study of Electromagnetic Waves in the Treatment of the Advanced Hepatocarcinoma
THBC002 |
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Scientific title:
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Étude de Phase II Pour déterminer l'efficacité Des Ondes électromagnétiques de Basse intensité administrées Par Voie Buccale Dans le Traitement du Cancer du Foie avancé |
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Date of first enrolment:
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February 2007 |
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Target sample size:
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0 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00440934 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Switzerland
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Contacts
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Name:
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Boris Pasche, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Cabinet Médical Avenue de la gare 6 |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- The patients must have a diagnosis of inoperable hepatocellular carcinoma.
- The patients who have an AFP level higher than 400 ng/ml and an appearance
characteristic of cancer of the liver do not need histological confirmation. These
patients must however have a negative serology for the antigen of surface of
hepatitis B If serology for this antigen is positive, they must have a rate of AFP
higher than 4000 ng/ml.
- Presence of one or more lesions measurable(s) according to criteria's RECIST.
Exclusion Criteria:
- Other anti-cancer treatments are not authorized during this study.
Age minimum:
18 Years
Age maximum:
95 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Carcinoma, Hepatocellular
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Intervention(s)
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Device: Amplitude-modulated electromagnetic fields
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Primary Outcome(s)
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• To determine disease free survival at 4 months while receiving the experimental treatment.
[Time Frame: 4 months]
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Response rate
[Time Frame: six months]
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Secondary Outcome(s)
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To determine the influence of the treatment on the hepatic function of patients with a diagnosis of cirrhosis. To determine the impact of the treatment by means of electromagnetic waves on the overall survival of patients.
[Time Frame: six months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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