Study Stopped
Poor patient accrual
A Study of Electromagnetic Waves in the Treatment of the Advanced Hepatocarcinoma
THBC002
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
1 other identifier
interventional
N/A
1 country
1
Brief Summary
Hepatocarcinoma (HCC) is the first cause of deaths due to cancer worldwide. More than one million two hundred thousand new patients are diagnosed each year. The prognosis of patients suffering from advanced hepatocarcinoma is poor with an average survival of less than six months. Phase I data suggest that low levels of electromagnetic fields administered intrabucally with a portable and programmable device are a safe and potentially effective treatment for advanced cancer. The device is connected to a spoon-like coupler placed in the patient's mouth during treatment. Patients with advanced HCC and limited therapeutic options will be offered treatment with a combination of frequencies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Feb 2007
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 24, 2007
CompletedFirst Posted
Study publicly available on registry
February 27, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedMay 6, 2008
May 1, 2008
10 months
February 24, 2007
May 2, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
• To determine disease free survival at 4 months while receiving the experimental treatment.
4 months
Response rate
six months
Secondary Outcomes (1)
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.
six months
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Other anti-cancer treatments are not authorized during this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pasche, Boris, M.D.lead
- Barbault, Alexandre, M.S.collaborator
Study Sites (1)
Cabinet Médical de l'Avenue de la gare 6
Lausanne, Canton of Vaud, 1003, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Boris Pasche, MD, PhD
Cabinet Médical Avenue de la gare 6
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDIV
Study Record Dates
First Submitted
February 24, 2007
First Posted
February 27, 2007
Study Start
February 1, 2007
Primary Completion
December 1, 2007
Study Completion
December 1, 2007
Last Updated
May 6, 2008
Record last verified: 2008-05