Endoesophageal Brachytherapy for Patients With Esophageal Cancer

NCT03335813 | Completed Results DMC FDA Device

• 1 other identifier: CASE5217
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Cancer

Keywords

brachytherapy; multichannel balloon applicator

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Radiation Treatment Volume

  Up to 6 cycles (6 weeks) of treatment

• Dose of Radiation to Organ at Risk (Bronchus)

  Up to 6 months of follow-up

• Dose of Radiation to Organ at Risk (Heart)

  Up to 6 months of follow-up

• Dose of Radiation to Organ at Risk (Aorta)

  Up to 6 months of follow-up

• Tumor Response Based on Resist Criteria

  Up to 6 months of follow-up

Study Arms (1)

brachytherapy with multichannel balloon applicator

EXPERIMENTAL

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

Device: Endoesophageal Brachytherapy

Interventions

Endoesophageal Brachytherapy DEVICE

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

brachytherapy with multichannel balloon applicator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Cleveland Clinic, Case Comprehensive Cancer Center

Weston, Florida, 33331, United States

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Results Point of Contact

• Title: Dr. John Greskovich
• Organization: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

taussigresearch@ccf.org

1-866-223-8100

Study Officials

• John F Greskovich, MD

  Cleveland Clinic, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2017
• First Posted: November 8, 2017
• Study Start: March 6, 2018
• Primary Completion: November 14, 2020
• Study Completion: December 8, 2020
• Last Updated: June 9, 2022
• Results First Posted: June 9, 2022

Record last verified: 2022-05

Locations

US (1)