Endoesophageal Brachytherapy for Patients With Esophageal Cancer

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-06

Study Completion Date

2020-12-08

Brief Summary

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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.

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Detailed Description

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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)

1. 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
2. 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.

Conditions

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Esophageal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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brachytherapy with multichannel balloon applicator

6 channel balloon re-positioning, multichannel brachytherapy applicator used to deliver localized radiation therapy to esophageal tumors

Group Type EXPERIMENTAL

Endoesophageal Brachytherapy

Intervention Type DEVICE

Balloon repositioning, multichannel brachytherapy applicator which has 6 channels instead of 3-tubes which will be used to deliver localized radiation

Interventions

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Endoesophageal Brachytherapy

Balloon repositioning, multichannel brachytherapy applicator which has 6 channels instead of 3-tubes which will be used to deliver localized radiation

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No