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NCT02467738 · ClinicalTrials.gov registry record · Early Phase 1
Surgical Resection and Intraoperative Cesium-131 Brachytherapy for Head and Neck Cancer
A Early Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 30
- Enrollment target
NCT02467738: Completed Early Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
NCT02467738 is a Early Phase 1 study that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University. The registered enrollment target is 30 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02467738, a Early Phase 1 study, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
This pilot clinical trial studies cesium Cs 131 brachytherapy in treating patients with head and neck cancer that has come back (recurrent) and can be removed by surgery. Brachytherapy, also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. Radioactive drugs, such as cesium Cs 131, may carry radiation directly to tumor cells and not harm normal cells. Permanently implanting cesium Cs 131 into the wound bed after surgery may help treat microscopic cancer cells that may be in the tissue after surgical removal of the tumor.
Primary Outcome
Will assess the impact of cesium Cs 131 on DFS by comparing the cohort to a matched historical control cohort. The distribution of DFS will be estimated using the Kaplan-Meier and a stratified log rank test will be used to test for differences between cohorts. Adjustment for other potential confounders will be performed using stratified Cox proportional hazards regression
Interventions
- RADIATION Brachytherapy
- PROCEDURE Conventional surgery
- DRUG Cesium-131
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2015-03-17 |
| Est. Completion | 2020-05-28 |
| Phase | Early Phase 1 |
What the finished NCT02467738 record still lists
NCT02467738 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (43% lower).
The record links to 0 conditions, and to 3 interventions - of which Brachytherapy is the first listed.
NCT02467738 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02467738 about?
NCT02467738 is a clinical study titled "Surgical Resection and Intraoperative Cesium-131 Brachytherapy for Head and Neck Cancer". This pilot clinical trial studies cesium Cs 131 brachytherapy in treating patients with head and neck cancer that has come back (recurrent) and can be removed by surgery. Brachytherapy, also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill t...
What is the current status of trial NCT02467738?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 30 participants. The study started on 2015-03-17. Estimated completion is 2020-05-28.
What interventions are being tested in trial NCT02467738?
The interventions under investigation include: Brachytherapy (RADIATION), Conventional surgery (PROCEDURE), Cesium-131 (DRUG).
Who is sponsoring clinical trial NCT02467738?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University, which has 138 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02467738's enrollment target sits among peer trials
30 807th of 2000 higher than 1,075 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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