- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00440934
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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. Therapies for hepatocarcinoma are limited. Resection of the primary tumor is the therapeutic approach of first choice when possible. Although this intervention results in long-term survival for some patients, only a minority of them are surgical candidates because of limitations due to tumor size, patient's overall condition or presence of hepatic cirrhosis.
Phase I data suggest that low levels of amplitude-modulated 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 HCC-specific frequencies.
The patients will be offered ambulatory treatment, which will be administered three times a day for 60 min until disease progression or death.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Vaud
-
Lausanne, Vaud, Switzerland, 1003
- Cabinet Médical de l'Avenue de la gare 6
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
• To determine disease free survival at 4 months while receiving the experimental treatment.
Time Frame: 4 months
|
4 months
|
Response rate
Time Frame: six months
|
six months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
six months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Boris Pasche, MD, PhD, Cabinet Médical Avenue de la gare 6
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- THBC 002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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