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Endoesophageal Brachytherapy for Patients With Esophageal Cancer

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ClinicalTrials.gov Identifier: NCT03335813
Recruitment Status : Recruiting
First Posted : November 8, 2017
Last Update Posted : March 8, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Device: Endoesophageal Brachytherapy Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Endoesophageal Brachytherapy for Patients With Esophageal Cancer: A Balloon Repositioning, Multichannel Radiation Applicator for Optimizing Treatment Delivery
Actual Study Start Date : December 21, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Dose of radiation delivered to 90% of tumor volume (D90) [ Time Frame: Up to 6 months of follow-up ]
  2. Volume of the tumor receiving the prescription dose (V100) [ Time Frame: Up to 6 months of follow-up ]

Secondary Outcome Measures :
  1. Radiation treatment volume [ Time Frame: Up to 6 cycles (6 weeks) of treatment ]
  2. Number of organs at risk [ Time Frame: Up to 6 months of follow-up ]
  3. Tumor response based on resist criteria [ Time Frame: Up to 6 months of follow-up ]
  4. Number of patients with esophageal ulceration [ Time Frame: Up to 6 cycles (6 weeks) of treatment ]
  5. Number of patients with esophageal fistula [ Time Frame: Up to 6 cycles (6 weeks) of treatment ]
  6. Number of patients with esophageal stricture [ Time Frame: Up to 6 cycles (6 weeks) of treatment ]
  7. Number of patients with need for dilation [ Time Frame: Up to 6 cycles (6 weeks) of treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03335813


Contacts
Contact: John F Greskovich, MD 954-659-5840 greskoj1@ccf.org

Locations
United States, Florida
Cleveland Clinic, Case Comprehensive Cancer Center Recruiting
Weston, Florida, United States, 33331
Contact: John F Greskovich, MD    954-659-5840    greskoj1@ccf.org   
Principal Investigator: John F Greskovich, MD         
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Principal Investigator: John F Greskovich, MD Cleveland Clinic, Case Comprehensive Cancer Center

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT03335813     History of Changes
Other Study ID Numbers: CASE5217
First Posted: November 8, 2017    Key Record Dates
Last Update Posted: March 8, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Case Comprehensive Cancer Center:
brachytherapy
multichannel balloon applicator

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases