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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


Phase 2
18 Years
95 Years
Not Enrolling
Both
Carcinoma, Hepatocellular

Thank you

Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

• To determine disease free survival at 4 months while receiving the experimental treatment.

Outcome Time Frame:

4 months

Safety Issue:

No

Principal Investigator

Boris Pasche, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cabinet Médical Avenue de la gare 6

Authority:

Switzerland: Laws and standards

Study ID:

THBC 002

NCT ID:

NCT00440934

Start Date:

February 2007

Completion Date:

December 2007

Related Keywords:

  • Carcinoma, Hepatocellular
  • carcinoma, hepatocellular
  • electromagnetic fields
  • Carcinoma
  • Carcinoma, Hepatocellular

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