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NCT04871516 · ClinicalTrials.gov registry record · NA
Radiation Therapy Boost Before Surgery for the Treatment of Non-metastatic Breast Cancer
A NA study of Anatomic Stage II Breast Cancer AJCC v8 and Anatomic Stage I Breast Cancer AJCC v8, sponsored by Rutgers, The State University of New Jersey.
- Active
- Registry status
- NA
- Development phase
- 103
- Enrollment target
- 11
- Study locations
NCT04871516: Active NA study of Anatomic Stage II Breast Cancer AJCC v8 and Anatomic Stage I Breast Cancer AJCC v8, sponsored by Rutgers, The State University of New Jersey.
NCT04871516 is a NA study of Anatomic Stage II Breast Cancer AJCC v8 and Anatomic Stage I Breast Cancer AJCC v8 that is active but no longer recruiting, run by Rutgers, The State University of New Jersey. The registered enrollment target is 103 participants, below the 355-participant average among 73 other Anatomic Stage II Breast Cancer AJCC v8 trials with a reported enrollment target (71% lower). The trial reports 11 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04871516, a NA study of Anatomic Stage II Breast Cancer AJCC v8 and Anatomic Stage I Breast Cancer AJCC v8, is active but no longer recruiting, sponsored by Rutgers, The State University of New Jersey.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 103 participants
- Enrollment target
- 11
- Study locations
Study Summary
This phase II trial investigates the safety of delivering a part (boost) of radiation treatment before breast surgery in treating patients with breast cancer that has not spread to other places in the body (non-metastatic). Radiation therapy uses high energy photons/electrons to kill tumor cells and shrink tumors. Delivering a boost radiation treatment before surgery when doctors can still visualize the tumor on imaging may help to better target the tumor and decrease the volume of normal irradiated tissue. By so doing, doctors may achieve better cosmetic outcomes and possibly better tumor control.
Primary Outcome
Wound complications will be assessed by the surgeon and radiation oncologist and graded using descriptions and grading scales found in the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 5 (CTCAE v 5.0). This will be calculated as a proportion based on the number of events in the study. Will report the proportion with a 95% confidence interval (CI) using the Clopper-Pearson method.
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- OTHER Questionnaire Administration
- RADIATION Radiation Boost
- RADIATION Whole Breast Irradiation
- PROCEDURE Therapeutic Surgical Procedure
Study Locations (11)
New Jersey
- Clara Maass Medical Center - Belleville
- RWJBarnabas Health-Trinitas Hospital and Comprehensive Care - Elizabeth
- The Cancer Institute of New Jersey Hamilton - Hamilton
- RWJBarnabas Health Jersey City Medical Center - Jersey City
- RWJBarnabas Health - Monmouth Medical Center Southern Campus - Lakewood
- Cooperman Barnabas Medical Center (Saint Barnabas Medical Center) - Livingston
- Rutgers Cancer Institute of New Jersey - New Brunswick
- Rutgers New Jersey Medical School - Newark
- RWJBarnabas Health - Newark Beth Israel Medical Center - Newark
- Robert Wood Johnson University Hospital Somerset - Somerville
- RWJBarnabas Health - Community Medical Center - Toms River
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2021-05-18 |
| Est. Completion | 2028-01-31 |
| Phase | NA |
What the registry record for NCT04871516 still lists
NCT04871516 is an interventional study that assigns participants to a tested intervention. The registered 103 participants enrollment target is mid-sized for trials with a published cap, below the 355-participant average among 73 other Anatomic Stage II Breast Cancer AJCC v8 trials with a reported enrollment target (71% lower).
The record links to 10 conditions, with Anatomic Stage II Breast Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Quality-of-Life Assessment is the first listed.
NCT04871516 lists 11 locations in 1 state (New Jersey).
Frequently Asked Questions
What is clinical trial NCT04871516 about?
NCT04871516 is a clinical study titled "Radiation Therapy Boost Before Surgery for the Treatment of Non-metastatic Breast Cancer". This phase II trial investigates the safety of delivering a part (boost) of radiation treatment before breast surgery in treating patients with breast cancer that has not spread to other places in the body (non-metastatic). Radiation therapy uses high energy photons/electrons to kill tumor cells and...
What is the current status of trial NCT04871516?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 103 participants. The study started on 2021-05-18. Estimated completion is 2028-01-31.
What conditions does trial NCT04871516 study?
This clinical trial studies the following conditions: Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Invasive Breast Carcinoma, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8.
What interventions are being tested in trial NCT04871516?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Questionnaire Administration (OTHER), Radiation Boost (RADIATION), Whole Breast Irradiation (RADIATION), Therapeutic Surgical Procedure (PROCEDURE).
Who is sponsoring clinical trial NCT04871516?
This trial is sponsored by Rutgers, The State University of New Jersey, which has 413 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04871516 being conducted?
This trial has 11 study locations across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04871516's enrollment target sits among peer trials
103 34th of 73 higher than 40 of 73 other Anatomic Stage II Breast Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anatomic Stage II Breast Cancer AJCC v8 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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