Endoesophageal Brachytherapy for Patients With Esophageal Cancer

Overview

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.

Full Title of Study: “Endoesophageal Brachytherapy for Patients With Esophageal Cancer: A Balloon Repositioning, Multichannel Radiation Applicator for Optimizing Treatment Delivery”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 14, 2020

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.

Interventions

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

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Dose of Radiation Delivered to 90% of Tumor Volume (D90)
    • Time Frame: 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)
    • Time Frame: 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 Measures

  • Radiation Treatment Volume
    • Time Frame: 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 (Bronchus)
    • Time Frame: 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.
  • Dose of Radiation to Organ at Risk (Heart)
    • Time Frame: 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)
    • Time Frame: 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.
  • Tumor Response Based on Resist Criteria
    • Time Frame: 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.
  • Number of Participants With Esophageal Ulceration
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: Up to 6 cycles (6 weeks) of treatment
    • Presence of an esophageal stricture
  • Number of Participants With the Need for Dilation
    • Time Frame: Up to 6 cycles (6 weeks) of treatment
    • Number of participants with the need for esophageal dilation

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Case Comprehensive Cancer Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • John F Greskovich, MD, Principal Investigator, Cleveland Clinic, Case Comprehensive Cancer Center

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.