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NCT05856773 · ClinicalTrials.gov registry record · Phase 3
Conventionally Fractionated vs. Hypofractionated Comprehensive Nodal Irradiation for Breast Cancer Using Pencil Beam Scanning Proton Therapy
A Phase 3 study of Breast Cancer, sponsored by Proton Collaborative Group.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 276
- Enrollment target
- 7
- Study locations
NCT05856773: Recruiting Phase 3 study of Breast Cancer, sponsored by Proton Collaborative Group.
NCT05856773 is a Phase 3 study of Breast Cancer that is actively recruiting participants, run by Proton Collaborative Group. The registered enrollment target is 276 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (90% lower). The trial reports 7 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05856773, a Phase 3 study of Breast Cancer, is actively recruiting participants, sponsored by Proton Collaborative Group.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 276 participants
- Enrollment target
- 7
- Study locations
Study Summary
The purpose of this research study is to learn more about the effects of using proton radiation therapy delivered over a shorter course of treatment (3 weeks) compared with a longer, standard course of treatment (5 weeks) for women with breast cancer who require radiotherapy to the breast/chest wall and regional lymph nodes.
Primary Outcome
This study will investigate if adjuvant comprehensive regional nodal radiotherapy to the breast or chest wall and regional lymph nodes including the axilla (levels I-III), supraclavicular (SCV), and internal mammary (IMN) lymph nodes using pencil beam scanning proton therapy delivered with a hypofractionated regimen results in rates of acute and late grade 3 or worse treatment-related skin and soft tissue toxicities that are non-inferior compared with rates in pencil beam scanning proton therapy
Conditions Studied
Interventions
- RADIATION Proton Therapy
Study Locations (7)
Florida
- University of Florida Proton Therapy Institute - Jacksonville
- Miami Cancer Institute - Miami
Arizona
- Mayo Clinic - Scottsdale
California
- California Protons Cancer Therapy Center - San Diego
Georgia
- Emory Proton Therapy Center - Atlanta
New York
- New York Proton Center - New York
Virginia
- Inova Schar Cancer Institute - Fairfax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 276 participants |
| Start Date | 2024-03-21 |
| Est. Completion | 2041-02 |
| Phase | Phase 3 |
What NCT05856773 shows while recruiting
NCT05856773 is an interventional study that assigns participants to a tested intervention. The registered 276 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which Proton Therapy is the first listed.
NCT05856773 lists 7 locations in 6 states (Florida, Arizona, California).
Frequently Asked Questions
What is clinical trial NCT05856773 about?
NCT05856773 is a clinical study titled "Conventionally Fractionated vs. Hypofractionated Comprehensive Nodal Irradiation for Breast Cancer Using Pencil Beam Scanning Proton Therapy". The purpose of this research study is to learn more about the effects of using proton radiation therapy delivered over a shorter course of treatment (3 weeks) compared with a longer, standard course of treatment (5 weeks) for women with breast cancer who require radiotherapy to the breast/chest wall...
What is the current status of trial NCT05856773?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 276 participants. The study started on 2024-03-21. Estimated completion is 2041-02.
What conditions does trial NCT05856773 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT05856773?
The interventions under investigation include: Proton Therapy (RADIATION).
Who is sponsoring clinical trial NCT05856773?
This trial is sponsored by Proton Collaborative Group, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05856773 being conducted?
This trial has 7 study locations across Arizona, California, Florida, Georgia, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05856773's enrollment target sits among peer trials
276 300th of 1224 higher than 923 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer 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.
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