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Completed

NCT Number: NCT03335813

Endoesophageal Brachytherapy for Patients With Esophageal Cancer

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic, Case Comprehensive Cancer Center

Weston, Florida, 33331, United States

About this study

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)

  • 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
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endoesophageal Brachytherapy

Device

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

Primary outcomes

  1. 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)

  2. 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 outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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

  7. 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

  8. Number of Particiapants With Esophageal Stricture

    Time frame: Up to 6 cycles (6 weeks) of treatment

    Presence of an esophageal stricture

  9. 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

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 8, 2017
Registry last updated
Jun 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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