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NCT05289466 · ClinicalTrials.gov registry record · NA
Oncoplastic Partial Mastectomy With Intraoperative Radiation Therapy (IORT) in Early Stage Breast Cancer Patients With Prior History of Chest Wall Radiation.
A NA study, sponsored by Saint John's Cancer Institute.
- Terminated
- Registry status
- NA
- Development phase
- 5
- Enrollment target
NCT05289466: Clinical Trial NA study, sponsored by Saint John's Cancer Institute.
NCT05289466 is a NA study that was terminated before completion, run by Saint John's Cancer Institute. The registered enrollment target is 5 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05289466, a NA study, was terminated before completion, sponsored by Saint John's Cancer Institute.
- TERMINATED
- Registry status
- NA
- Development phase
- 5 participants
- Enrollment target
Study Summary
Prospective, Non-randomized, Single-arm.The objectives of this study are to evaluate cosmesis and perioperative complications associated with the use of intraoperative radiotherapy (IORT) at the time of partial mastectomy in patients with breast cancer and a prior history of radiation therapy. Secondary objectives include evaluating effectiveness of partial mastectomy with IORT, measured by local, regional and distant recurrence, mastectomy rate, and disease-specific and overall survival.
Primary Outcome
The BREAST-Q is a validated patient-reported outcome measure of breast related satisfaction and quality of life, including psychosocial, sexual well-being, and physical domains. Data for cosmetic outcomes will be summarized at the study's completion. This data will be compared to patients included in the IORT Registry that did not have a history of prior irradiation utilizing appropriate statistical tests and models.
Interventions
- RADIATION Intraoperative Radiotherapy
- PROCEDURE Oncoplastic partial mastectomy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2021-12-16 |
| Est. Completion | 2024-10-23 |
| Phase | NA |
Why NCT05289466 stopped before completion
NCT05289466 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 2 interventions - of which Intraoperative Radiotherapy is the first listed.
NCT05289466 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05289466 about?
NCT05289466 is a clinical study titled "Oncoplastic Partial Mastectomy With Intraoperative Radiation Therapy (IORT) in Early Stage Breast Cancer Patients With Prior History of Chest Wall Radiation.". Prospective, Non-randomized, Single-arm.The objectives of this study are to evaluate cosmesis and perioperative complications associated with the use of intraoperative radiotherapy (IORT) at the time of partial mastectomy in patients with breast cancer and a prior history of radiation therapy. Secon...
What is the current status of trial NCT05289466?
This trial is currently terminated. It is a NA study. The enrollment target is 5 participants. The study started on 2021-12-16. Estimated completion is 2024-10-23.
What interventions are being tested in trial NCT05289466?
The interventions under investigation include: Intraoperative Radiotherapy (RADIATION), Oncoplastic partial mastectomy (PROCEDURE).
Who is sponsoring clinical trial NCT05289466?
This trial is sponsored by Saint John's Cancer Institute, which has 19 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05289466's enrollment target sits among peer trials
5 1988th of 2000 higher than 5 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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