Trial Outcomes & Findings for Endoesophageal Brachytherapy for Patients With Esophageal Cancer (NCT NCT03335813)
NCT ID: NCT03335813
Last Updated: 2022-06-09
Results Overview
Percent of prescription dose received by 90% of PTV (planning target volume)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
7 participants
Primary outcome timeframe
Up to 6 months of follow-up
Results posted on
2022-06-09
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
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
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Endoesophageal Brachytherapy for Patients With Esophageal Cancer
Baseline characteristics by cohort
| Measure |
Brachytherapy With Multichannel Balloon Applicator
n=7 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to 6 months of follow-upPopulation: Number of participants who received treatment
Percent of prescription dose received by 90% of PTV (planning target volume)
Outcome measures
| Measure |
Brachytherapy With Multichannel Balloon Applicator
n=6 Participants
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
|
|---|---|
|
Dose of Radiation Delivered to 90% of Tumor Volume (D90)
|
105.5 percentage of Prescription dose
Interval 69.84 to 115.34
|
PRIMARY outcome
Timeframe: Up to 6 months of follow-upPopulation: Number of participants who received treatment
Percent volume of the tumor receiving 100% of the prescription dose calculated as the mean from the total weekly HDR brachytherapy treatment plans
Outcome measures
| Measure |
Brachytherapy With Multichannel Balloon Applicator
n=6 Participants
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
|
|---|---|
|
Percent Volume of the Tumor Receiving the Prescription Dose (V100)
|
94.3 percentage of volume
Interval 66.0 to 97.9
|
SECONDARY outcome
Timeframe: Up to 6 cycles (6 weeks) of treatmentPopulation: Number of Participants who received treatment
Volume of tissue, both tumor plus normal tissue volume, receiving 100% of the prescription dose
Outcome measures
| Measure |
Brachytherapy With Multichannel Balloon Applicator
n=6 Participants
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
|
|---|---|
|
Radiation Treatment Volume
|
52.13 cc
Interval 38.93 to 90.4
|
SECONDARY outcome
Timeframe: Up to 6 months of follow-upPopulation: Number of Participants who had tumors in proximity to the specified organ
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.
Outcome measures
| Measure |
Brachytherapy With Multichannel Balloon Applicator
n=4 Participants
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
|
|---|---|
|
Dose of Radiation to Organ at Risk (Bronchus)
|
2.38 Gy
Interval 0.76 to 3.79
|
SECONDARY outcome
Timeframe: Up to 6 months of follow-upPopulation: Number of Participants who had tumors in proximity to the specified organ
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.
Outcome measures
| Measure |
Brachytherapy With Multichannel Balloon Applicator
n=4 Participants
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
|
|---|---|
|
Dose of Radiation to Organ at Risk (Heart)
|
3.22 Gy
Interval 2.44 to 4.18
|
SECONDARY outcome
Timeframe: Up to 6 months of follow-upPopulation: Number of Participants who had tumors in proximity to the specified organ
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.
Outcome measures
| Measure |
Brachytherapy With Multichannel Balloon Applicator
n=6 Participants
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
|
|---|---|
|
Dose of Radiation to Organ at Risk (Aorta)
|
3.19 Gy
Interval 1.86 to 5.62
|
SECONDARY outcome
Timeframe: Up to 6 months of follow-upPopulation: All Participants who received treatment
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.
Outcome measures
| Measure |
Brachytherapy With Multichannel Balloon Applicator
n=6 Participants
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
|
|---|---|
|
Tumor Response Based on Resist Criteria
Endoscopic CR
|
5 Participants
|
|
Tumor Response Based on Resist Criteria
Endoscopic PR
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 6 cycles (6 weeks) of treatmentPopulation: All Participants who received treatment
Presence of an ulceration of the mucosa in area of brachytherapy treatment
Outcome measures
| Measure |
Brachytherapy With Multichannel Balloon Applicator
n=6 Participants
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
|
|---|---|
|
Number of Participants With Esophageal Ulceration
|
5 Participants
|
SECONDARY outcome
Timeframe: Up to 6 cycles (6 weeks) of treatmentPopulation: All Participants who received treatment
Presence of a fistula between the esophagus and trachea, mainstem bronchus or mediastinum
Outcome measures
| Measure |
Brachytherapy With Multichannel Balloon Applicator
n=6 Participants
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
|
|---|---|
|
Number of Participants With Esophageal Fistula
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 6 cycles (6 weeks) of treatmentPopulation: All Participants who received treatment
Presence of an esophageal stricture
Outcome measures
| Measure |
Brachytherapy With Multichannel Balloon Applicator
n=6 Participants
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
|
|---|---|
|
Number of Particiapants With Esophageal Stricture
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 6 cycles (6 weeks) of treatmentPopulation: All participants who received treatment
Number of participants with the need for esophageal dilation
Outcome measures
| Measure |
Brachytherapy With Multichannel Balloon Applicator
n=6 Participants
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
|
|---|---|
|
Number of Participants With the Need for Dilation
|
3 Participants
|
POST_HOC outcome
Timeframe: Up to 6 cycles (6 weeks) of treatmentPopulation: Number of participants who received treatment
Need for esophageal stent
Outcome measures
| Measure |
Brachytherapy With Multichannel Balloon Applicator
n=6 Participants
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
|
|---|---|
|
Number of Participants With Need for Stent Placement
|
2 Participants
|
Adverse Events
Brachytherapy With Multichannel Balloon Applicator
Serious events: 5 serious events
Other events: 0 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Brachytherapy With Multichannel Balloon Applicator
n=7 participants at risk
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
|
|---|---|
|
General disorders
Death, NOS
|
14.3%
1/7 • 6 months
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. John Greskovich
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Phone: 1-866-223-8100
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place