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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
Balloon repositioning, multichannel brachytherapy applicator which has 6 channels instead of 3-tubes which will be used to deliver localized radiation
Cleveland Clinic, Case Comprehensive Cancer Center
Weston, Florida, United States
Dose of Radiation Delivered to 90% of Tumor Volume (D90)
Percent of prescription dose received by 90% of PTV (planning target volume)
Time frame: Up to 6 months of follow-up
Percent Volume of the Tumor Receiving the Prescription Dose (V100)
Percent volume of the tumor receiving 100% of the prescription dose calculated as the mean from the total weekly HDR brachytherapy treatment plans
Time frame: Up to 6 months of follow-up
Radiation Treatment Volume
Volume of tissue, both tumor plus normal tissue volume, receiving 100% of the prescription dose
Time frame: Up to 6 cycles (6 weeks) of treatment
Dose of Radiation to Organ at Risk (Bronchus)
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.
Time frame: Up to 6 months of follow-up
Dose of Radiation to Organ at Risk (Heart)
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.
Time frame: Up to 6 months of follow-up
Dose of Radiation to Organ at Risk (Aorta)
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.
Time frame: Up to 6 months of follow-up
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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Tumor Response Based on Resist Criteria
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.
Time frame: Up to 6 months of follow-up
Number of Participants With Esophageal Ulceration
Presence of an ulceration of the mucosa in area of brachytherapy treatment
Time frame: Up to 6 cycles (6 weeks) of treatment
Number of Participants With Esophageal Fistula
Presence of a fistula between the esophagus and trachea, mainstem bronchus or mediastinum
Time frame: Up to 6 cycles (6 weeks) of treatment
Number of Particiapants With Esophageal Stricture
Presence of an esophageal stricture
Time frame: Up to 6 cycles (6 weeks) of treatment
Number of Participants With the Need for Dilation
Number of participants with the need for esophageal dilation
Time frame: Up to 6 cycles (6 weeks) of treatment