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NCT01839838 · ClinicalTrials.gov registry record · Phase 1
APBI Proton Feasibility and Phase II Study
A Phase 1 study, sponsored by Abramson Cancer Center at Penn Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT01839838: Completed Phase 1 study, sponsored by Abramson Cancer Center at Penn Medicine.
NCT01839838 is a Phase 1 study that has completed, run by Abramson Cancer Center at Penn Medicine. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01839838, a Phase 1 study, has completed, sponsored by Abramson Cancer Center at Penn Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
The overall objectives of the study are to establish feasibility and acute side effects of accelerated partial breast irradiation therapy, along with more long-term side effects and clinical efficacy of treatment.
Primary Outcome
Number of Participants that meets the criteria of feasibility and acute toxicity will be reported. The objectives were both feasibility and acute toxicity profile of accelerated partial breast radiation using protons. Feasibility was based on multiple radiation planning and treatment parameters: (1) a patient cannot be given treatment because anatomy is such that a dosimetrically satisfactory treatment plan cannot be devised; (2) a patient is unable to tolerate more than 20% of treatments using
Interventions
- RADIATION Proton Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2013-04-22 |
| Est. Completion | 2022-12-23 |
| Phase | Phase 1 |
What the finished NCT01839838 record still lists
NCT01839838 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 1 intervention - of which Proton Therapy is the first listed.
NCT01839838 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01839838 about?
NCT01839838 is a clinical study titled "APBI Proton Feasibility and Phase II Study". The overall objectives of the study are to establish feasibility and acute side effects of accelerated partial breast irradiation therapy, along with more long-term side effects and clinical efficacy of treatment.
What is the current status of trial NCT01839838?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2013-04-22. Estimated completion is 2022-12-23.
What interventions are being tested in trial NCT01839838?
The interventions under investigation include: Proton Therapy (RADIATION).
Who is sponsoring clinical trial NCT01839838?
This trial is sponsored by Abramson Cancer Center at Penn Medicine, which has 402 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01839838's enrollment target sits among peer trials
40 1130th of 2000 higher than 810 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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