Endoesophageal Brachytherapy for Patients With Esophageal Cancer

Endoesophageal Brachytherapy for Patients With Esophageal Cancer: A Balloon Repositioning, Multichannel Radiation Applicator for Optimizing Treatment Delivery

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.

Study Overview

• Status: Completed
• Conditions: Esophageal Cancer
• Intervention / Treatment: Device: Endoesophageal Brachytherapy

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.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Weston, Florida, United States, 33331
      • Cleveland Clinic, Case Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: brachytherapy with multichannel balloon applicator; 6 channel balloon re-positioning, multichannel brachytherapy applicator used to deliver localized radiation therapy to esophageal tumors	Device: Endoesophageal Brachytherapy; Balloon repositioning, multichannel brachytherapy applicator which has 6 channels instead of 3-tubes which will be used to deliver localized radiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose of Radiation Delivered to 90% of Tumor Volume (D90)	Percent of prescription dose received by 90% of PTV (planning target volume)	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	Up to 6 months of follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiation Treatment Volume	Volume of tissue, both tumor plus normal tissue volume, receiving 100% of the prescription dose	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.	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.	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.	Up to 6 months of follow-up
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.	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	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	Up to 6 cycles (6 weeks) of treatment
Number of Particiapants With Esophageal Stricture	Presence of an esophageal stricture	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	Up to 6 cycles (6 weeks) of treatment

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Investigators: Principal Investigator: John F Greskovich, MD, Cleveland Clinic, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2018
• Primary Completion (Actual): November 14, 2020
• Study Completion (Actual): December 8, 2020

Study Registration Dates

• First Submitted: November 3, 2017
• First Submitted That Met QC Criteria: November 6, 2017
• First Posted (Actual): November 8, 2017

Study Record Updates

• Last Update Posted (Actual): June 9, 2022
• Last Update Submitted That Met QC Criteria: May 17, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: brachytherapy; multichannel balloon applicator
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms
• Other Study ID Numbers: CASE5217

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No