N/A
N=7
Endoesophageal Brachytherapy for Patients With Esophageal Cancer
Esophageal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03335813 ↗Enrolled (actual)
7
Serious AEs
71.4%
Results posted
Jun 2022
Primary outcome: Primary: Dose of Radiation Delivered to 90% of Tumor Volume (D90) — 105.5 percentage of Prescription dose
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Endoesophageal Brachytherapy (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Case Comprehensive Cancer Center
- Primary completion
- Nov 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dose of Radiation Delivered to 90% of Tumor Volume (D90) |
105.5 | — |
| PRIMARY Percent Volume of the Tumor Receiving the Prescription Dose (V100) |
94.3 | — |
| SECONDARY Radiation Treatment Volume |
52.13 | — |
| SECONDARY Dose of Radiation to Organ at Risk (Bronchus) |
2.38 | — |
| SECONDARY Dose of Radiation to Organ at Risk (Heart) |
3.22 | — |
| SECONDARY Dose of Radiation to Organ at Risk (Aorta) |
3.19 | — |
| SECONDARY Tumor Response Based on Resist Criteria |
5; 1 | — |
| SECONDARY Number of Participants With Esophageal Ulceration |
5 | — |
| SECONDARY Number of Participants With Esophageal Fistula |
— | — |
| SECONDARY Number of Particiapants With Esophageal Stricture |
3 | — |
| SECONDARY Number of Participants With the Need for Dilation |
3 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03335813). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.