Endoesophageal Brachytherapy for Patients With Esophageal Cancer

Not Applicable

Completed

Conditions: Esophageal Cancer

Interventions: Device: Endoesophageal Brachytherapy

Registration Number: NCT03335813

Lead Sponsor: Case Comprehensive Cancer Center

Brief 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.

Detailed 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)

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 7

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
brachytherapy with multichannel balloon applicator	Endoesophageal Brachytherapy	6 channel balloon re-positioning, multichannel brachytherapy applicator used to deliver localized radiation therapy to esophageal tumors

Primary Outcome Measures

Name	Time	Method
Dose of Radiation Delivered to 90% of Tumor Volume (D90)	Up to 6 months of follow-up	Percent of prescription dose received by 90% of PTV (planning target volume)
Percent Volume of the Tumor Receiving the Prescription Dose (V100)	Up to 6 months of follow-up	Percent volume of the tumor receiving 100% of the prescription dose calculated as the mean from the total weekly HDR brachytherapy treatment plans

Secondary Outcome Measures

Name	Time	Method
Dose of Radiation to Organ at Risk (Bronchus)	Up to 6 months of follow-up	Dose to 1cc volume of the trachea-mainstem bronchus calculated as the mean dose from the total weekly HDR brachytherapy treatment plans for the 4 participants who had tumors in proximity to the trachea or mainstem bronchus.
Tumor Response Based on Resist Criteria	Up to 6 months of follow-up	Tumor response determined by endoscopic evaluation of tumor at time of last brachytherapy treatment. Endoscopic CR is defined as no visible tumor at end of treatment -on endoscopy exam and PR is defined as a persistent tumor at the end of treatment.
Radiation Treatment Volume	Up to 6 cycles (6 weeks) of treatment	Volume of tissue, both tumor plus normal tissue volume, receiving 100% of the prescription dose
Dose of Radiation to Organ at Risk (Heart)	Up to 6 months of follow-up	Dose to 1 cc volume of the heart calculated as the mean dose from the total weekly HDR brachytherapy treatment plans for the 4 participants who had tumors in proximity to the heart.
Dose of Radiation to Organ at Risk (Aorta)	Up to 6 months of follow-up	Dose to 1 cc volume of the aorta calculated as the mean dose from the total weekly HDR brachytherapy treatment plans for the 6 participants who had tumors in proximity to the aorta.
Number of Participants With Esophageal Ulceration	Up to 6 cycles (6 weeks) of treatment	Presence of an ulceration of the mucosa in area of brachytherapy treatment
Number of Participants With Esophageal Fistula	Up to 6 cycles (6 weeks) of treatment	Presence of a fistula between the esophagus and trachea, mainstem bronchus or mediastinum
Number of Particiapants With Esophageal Stricture	Up to 6 cycles (6 weeks) of treatment	Presence of an esophageal stricture
Number of Participants With the Need for Dilation	Up to 6 cycles (6 weeks) of treatment	Number of participants with the need for esophageal dilation