Endoesophageal Brachytherapy for Patients With Esophageal Cancer
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|ClinicalTrials.gov Identifier: NCT03335813|
Recruitment Status : Recruiting
First Posted : November 8, 2017
Last Update Posted : March 8, 2018
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Cancer||Device: Endoesophageal Brachytherapy||Not Applicable|
Primary Objective Pilot study of multichannel endoesophageal brachytherapy applicator to determine dose distribution and conformality of a 6 channel balloon repositioning applicator.
- 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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Endoesophageal Brachytherapy for Patients With Esophageal Cancer: A Balloon Repositioning, Multichannel Radiation Applicator for Optimizing Treatment Delivery|
|Actual Study Start Date :||December 21, 2017|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 2019|
Experimental: brachytherapy with multichannel balloon applicator
6 channel balloon re-positioning, multichannel brachytherapy applicator used to deliver localized radiation therapy to esophageal tumors
Device: 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) [ Time Frame: Up to 6 months of follow-up ]
- Volume of the tumor receiving the prescription dose (V100) [ Time Frame: Up to 6 months of follow-up ]
- Radiation treatment volume [ Time Frame: Up to 6 cycles (6 weeks) of treatment ]
- Number of organs at risk [ Time Frame: Up to 6 months of follow-up ]
- Tumor response based on resist criteria [ Time Frame: Up to 6 months of follow-up ]
- Number of patients with esophageal ulceration [ Time Frame: Up to 6 cycles (6 weeks) of treatment ]
- Number of patients with esophageal fistula [ Time Frame: Up to 6 cycles (6 weeks) of treatment ]
- Number of patients with esophageal stricture [ Time Frame: Up to 6 cycles (6 weeks) of treatment ]
- Number of patients with need for dilation [ Time Frame: Up to 6 cycles (6 weeks) of treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03335813
|Contact: John F Greskovich, MDfirstname.lastname@example.org|
|United States, Florida|
|Cleveland Clinic, Case Comprehensive Cancer Center||Recruiting|
|Weston, Florida, United States, 33331|
|Contact: John F Greskovich, MD 954-659-5840 email@example.com|
|Principal Investigator: John F Greskovich, MD|
|Principal Investigator:||John F Greskovich, MD||Cleveland Clinic, Case Comprehensive Cancer Center|