Endoesophageal Brachytherapy for Patients With Esophageal Cancer

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03335813
• Other study ID #: CASE5217
• Status: Completed
• Phase: N/A
• Start date: March 6, 2018
• Est. completion date: December 8, 2020

Study information

• Verified date: May 2022
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: December 8, 2020
• Est. primary completion date: November 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Cleveland Clinic, Case Comprehensive Cancer Center	Weston	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of Particiapants With Esophageal Stricture	Presence of an esophageal stricture	Up to 6 cycles (6 weeks) of treatment
Secondary	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