Esophageal Cancer
Conditions
Keywords
brachytherapy, multichannel balloon applicator
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.
Interventions
DEVICEEndoesophageal Brachytherapy
Balloon repositioning, multichannel brachytherapy applicator which has 6 channels instead of 3-tubes which will be used to deliver localized radiation
Sponsors
Case Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose of Radiation Delivered to 90% of Tumor Volume (D90) | 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| Dose of Radiation to Organ at Risk (Heart) | 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. |
| Number of Participants With Esophageal Fistula | Up to 6 cycles (6 weeks) of treatment | Presence of a fistula between the esophagus and trachea, mainstem bronchus or mediastinum |
| Dose of Radiation to Organ at Risk (Aorta) | 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. |
| Radiation Treatment Volume | Up to 6 cycles (6 weeks) of treatment | Volume of tissue, both tumor plus normal tissue volume, receiving 100% of the prescription dose |
| Number of Participants With Esophageal Ulceration | Up to 6 cycles (6 weeks) of treatment | Presence of an ulceration of the mucosa in area of brachytherapy treatment |
| Number of Particiapants With Esophageal Stricture | Up to 6 cycles (6 weeks) of treatment | Presence of an esophageal stricture |
| Number of Participants With the Need for Dilation | Up to 6 cycles (6 weeks) of treatment | Number of participants with the need for esophageal dilation |
| Tumor Response Based on Resist Criteria | 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. |
| Dose of Radiation to Organ at Risk (Bronchus) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Brachytherapy With Multichannel Balloon Applicator 6 channel balloon re-positioning, multichannel brachytherapy applicator used to deliver localized radiation therapy to esophageal tumors
Endoesophageal Brachytherapy: Balloon repositioning, multichannel brachytherapy applicator which has 6 channels instead of 3-tubes which will be used to deliver localized radiation | 7 |
| Total | 7 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Brachytherapy With Multichannel Balloon Applicator |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 7 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 7 Participants |
| Region of Enrollment United States | 7 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 5 / 7 |
| other Total, other adverse events | 0 / 7 |
| serious Total, serious adverse events | 5 / 7 |
Outcome results
Primary
Dose of Radiation Delivered to 90% of Tumor Volume (D90)
Percent of prescription dose received by 90% of PTV (planning target volume)
Time frame: Up to 6 months of follow-up
Population: Number of participants who received treatment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Brachytherapy With Multichannel Balloon Applicator | Dose of Radiation Delivered to 90% of Tumor Volume (D90) | 105.5 percentage of Prescription dose |
Primary
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
Time frame: Up to 6 months of follow-up
Population: Number of participants who received treatment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Brachytherapy With Multichannel Balloon Applicator | Percent Volume of the Tumor Receiving the Prescription Dose (V100) | 94.3 percentage of volume |
Secondary
Dose of Radiation to Organ at Risk (Aorta)
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.
Time frame: Up to 6 months of follow-up
Population: Number of Participants who had tumors in proximity to the specified organ
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Brachytherapy With Multichannel Balloon Applicator | Dose of Radiation to Organ at Risk (Aorta) | 3.19 Gy |
Secondary
Dose of Radiation to Organ at Risk (Bronchus)
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.
Time frame: Up to 6 months of follow-up
Population: Number of Participants who had tumors in proximity to the specified organ
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Brachytherapy With Multichannel Balloon Applicator | Dose of Radiation to Organ at Risk (Bronchus) | 2.38 Gy |
Secondary
Dose of Radiation to Organ at Risk (Heart)
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.
Time frame: Up to 6 months of follow-up
Population: Number of Participants who had tumors in proximity to the specified organ
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Brachytherapy With Multichannel Balloon Applicator | Dose of Radiation to Organ at Risk (Heart) | 3.22 Gy |
Secondary
Number of Particiapants With Esophageal Stricture
Presence of an esophageal stricture
Time frame: Up to 6 cycles (6 weeks) of treatment
Population: All Participants who received treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Brachytherapy With Multichannel Balloon Applicator | Number of Particiapants With Esophageal Stricture | 3 Participants |
Secondary
Number of Participants With Esophageal Fistula
Presence of a fistula between the esophagus and trachea, mainstem bronchus or mediastinum
Time frame: Up to 6 cycles (6 weeks) of treatment
Population: All Participants who received treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Brachytherapy With Multichannel Balloon Applicator | Number of Participants With Esophageal Fistula | 0 Participants |
Secondary
Number of Participants With Esophageal Ulceration
Presence of an ulceration of the mucosa in area of brachytherapy treatment
Time frame: Up to 6 cycles (6 weeks) of treatment
Population: All Participants who received treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Brachytherapy With Multichannel Balloon Applicator | Number of Participants With Esophageal Ulceration | 5 Participants |
Secondary
Number of Participants With the Need for Dilation
Number of participants with the need for esophageal dilation
Time frame: Up to 6 cycles (6 weeks) of treatment
Population: All participants who received treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Brachytherapy With Multichannel Balloon Applicator | Number of Participants With the Need for Dilation | 3 Participants |
Secondary
Radiation Treatment Volume
Volume of tissue, both tumor plus normal tissue volume, receiving 100% of the prescription dose
Time frame: Up to 6 cycles (6 weeks) of treatment
Population: Number of Participants who received treatment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Brachytherapy With Multichannel Balloon Applicator | Radiation Treatment Volume | 52.13 cc |
Secondary
Tumor Response Based on Resist Criteria
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.
Time frame: Up to 6 months of follow-up
Population: All Participants who received treatment
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Brachytherapy With Multichannel Balloon Applicator | Tumor Response Based on Resist Criteria | Endoscopic CR | 5 Participants |
| Brachytherapy With Multichannel Balloon Applicator | Tumor Response Based on Resist Criteria | Endoscopic PR | 1 Participants |
Post Hoc
Number of Participants With Need for Stent Placement
Need for esophageal stent
Time frame: Up to 6 cycles (6 weeks) of treatment
Population: Number of participants who received treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Brachytherapy With Multichannel Balloon Applicator | Number of Participants With Need for Stent Placement | 2 Participants |