Esophageal Cancer Clinical Trial
Endoesophageal Brachytherapy for Patients With Esophageal Cancer
Summary
Depending upon the cancer stage, esophageal cancer can be treated with surgery, chemotherapy, radiation therapy, or a combination of these modalities. Sometimes in addition to external radiation therapy or instead of external radiation therapy, select patients with esophageal cancer may benefit from localized radiation to the tumor, called esophageal brachytherapy. There are many different radiation techniques and delivery approaches for this type of specialized radiation therapy, and the purpose of this document is to provide a written summary of an innovative delivery method.
Full Description
Primary Objective Pilot study of multichannel endoesophageal brachytherapy applicator to determine dose distribution and conformality of a 6 channel balloon repositioning applicator.
Secondary Objective(s)
To collect data in order to show how the 6-tube endoesophageal brachytherapy technique will be an improvement (more conformed dose distribution) over a previously designed 3-tube endoesophageal brachytherapy technique in patients who are candidates for esophageal brachytherapy
To evaluate acute toxicity of novel endoesophageal brachytherapy applicator.
Study Design
This innovative study will be an improvement over a previously designed 3-tube endoesophageal brachytherapy technique in patients who are candidates for esophageal brachytherapy. The brachytherapy planning process will utilize a novel multichannel balloon applicator.
The initial treatment session will occur after the patient has been found to be eligible, the consent form has been completed, and the treatment plan has been created. The patient will undergo subsequent weekly treatments for 3 to 6 weeks after the initial treatment.
The subject will be expected to participate in the trial throughout its entirety. The participation period is 6 months of which the patient will be evaluated and seen at months 3 and 6.
Eligibility Criteria
Inclusion Criteria:
Biopsy-proved esophageal adenocarcinoma or squamous cell carcinoma
Disease that can be encompassed in the radiotherapy treatment field
Women of childbearing potential must practice adequate contraception
Subjects must have the ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
Concurrent chemotherapy at the time of brachytherapy treatments
Tracheal or bronchial involvement
Cervical esophagus location
Stenosis that cannot be bypassed or dilated to allow for applicator placement
Not willing or unable to provide informed consent
History of esophageal fistula
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There is 1 Location for this study
Weston Florida, 33331, United States
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