- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00534664
Phase I/II Study of Amplitude-Modulated Electromagnetic Fields in the Treatment of Advanced Hepatocellular Carcinoma (TheraBionic)
September 24, 2007 updated by: University of Sao Paulo
Phase II Study to Determine the Effectiveness of Intrabuccally Administered Amplitude-Modulated Electromagnetic Fields in the Treatment of Advanced Hepatocellular Carcinoma
The goal of this study is to investigate the safety and feasibility of treating patients with advanced hepatocellular carcinoma with a noninvasive device administering low level of amplitude-modulated electromagnetic fields.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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São Paulo, Brazil, 05403-000
- Disciplina de Transplante e Cirurgia do Fígado
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Advanced biopsy-proven HCC
- Performance status ECOG 0-1
- Patients with Child Pugh A and B cirrhosis scores
- Absence of medical or psychiatric contraindication which, in the opinion of the treating investigator, would make the patient's participation in this trial inappropriate.
- Presence of one or more measurable lesion(s) according to the RECIST criteria.
- Lesions treated with chemoembolization or ablation by means of radio frequencies will not be considered measurable in this study.
- Patients on a liver transplant waiting list may be included
- Patient must not have curative treatment options other than liver transplant
- Patient may have been treated with intrahepatic treatment (chemoembolization or intrahepatic chemotherapy) or conventional chemotherapy or sorafenib or other experimental therapies prior to study entry. There is no limit for the number of prior therapies
- Extra hepatic metastases do not constitute an exclusion criterion, except for active CNS metastases.
- At least 4 weeks must have elapsed since administration of any anti-cancer treatment.
- Other anti-cancer treatments are not permitted during this study
- Patients must be more than 18 old and must be able to understand and sign an informed consent.
- Patient must agree to be followed up according to the study protocol.
- Patients may have either stable disease or disease progression according to the principal investigator assessment.
- Patients who carry a pacemaker or any other implantable electronic device are not allowed in the study
Exclusion Criteria:
- Suspected or biopsy confirmed brain metastases
- Patients with hepatic cirrhosis with Child-Pugh class C
- Patients who have received a liver transplant.
- Patients who had a surgical resection of the disease and who do not have measurable disease.
- Pregnant women
- Patients who still show objective response (complete or partial response) according to the RECIST criteria due to the last anti-cancer therapy
- Patients diagnosed with another type of cancer (excluding basal cell carcinoma) during the last five last years or whose cancer diagnosed previously is not in remission
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Frederico P Costa, MD, Disciplina de Transplante e Cirurgia do Fígado
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2005
Study Completion (Actual)
February 1, 2007
Study Registration Dates
First Submitted
September 24, 2007
First Submitted That Met QC Criteria
September 24, 2007
First Posted (Estimate)
September 26, 2007
Study Record Updates
Last Update Posted (Estimate)
September 26, 2007
Last Update Submitted That Met QC Criteria
September 24, 2007
Last Verified
September 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- THBC-HCC-01
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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