Clinical trial NCT03335813: Endoesophageal Brachytherapy for Patients With Esophageal Cancer
Official title: Endoesophageal Brachytherapy for Patients With Esophageal Cancer: A Balloon Repositioning, Multichannel Radiation Applicator for Optimizing Treatment Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Esophageal Cancer
Keywords: brachytherapy
multichannel balloon applicator
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2017-11-08
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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

Primary outcomes:
measure: Dose of Radiation Delivered to 90% of Tumor Volume (D90)
timeFrame: Up to 6 months of follow-up
measure: Percent Volume of the Tumor Receiving the Prescription Dose (V100)
timeFrame: Up to 6 months of follow-up
Secondary outcomes:
measure: Radiation Treatment Volume
timeFrame: Up to 6 cycles (6 weeks) of treatment
measure: Dose of Radiation to Organ at Risk (Bronchus)
timeFrame: Up to 6 months of follow-up
measure: Dose of Radiation to Organ at Risk (Heart)
timeFrame: Up to 6 months of follow-up
measure: Dose of Radiation to Organ at Risk (Aorta)
timeFrame: Up to 6 months of follow-up
measure: Tumor Response Based on Resist Criteria
timeFrame: Up to 6 months of follow-up
measure: Number of Participants With Esophageal Ulceration
timeFrame: Up to 6 cycles (6 weeks) of treatment
measure: Number of Participants With Esophageal Fistula
timeFrame: Up to 6 cycles (6 weeks) of treatment
measure: Number of Particiapants With Esophageal Stricture
timeFrame: Up to 6 cycles (6 weeks) of treatment
measure: Number of Participants With the Need for Dilation
timeFrame: Up to 6 cycles (6 weeks) of treatment
Other outcomes:
Locations:
city: Weston
country: United States
facility: Cleveland Clinic, Case Comprehensive Cancer Center
state: Florida
Study officials:
affiliation: Cleveland Clinic, Case Comprehensive Cancer Center
name: John F Greskovich, MD
role: PRINCIPAL_INVESTIGATOR
References: