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NCT03581136 · ClinicalTrials.gov registry record · NA
Phase II Multi-center Trial Evaluating 5 Fraction Stereotactic Partial Breast Irradiation Using Gammapod
A NA study of Breast Cancer, sponsored by University of Texas Southwestern Medical Center.
- Active
- Registry status
- NA
- Development phase
- 74
- Enrollment target
- 2
- Study locations
NCT03581136: Active NA study of Breast Cancer, sponsored by University of Texas Southwestern Medical Center.
NCT03581136 is a NA study of Breast Cancer that is active but no longer recruiting, run by University of Texas Southwestern Medical Center. The registered enrollment target is 74 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (97% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03581136, a NA study of Breast Cancer, is active but no longer recruiting, sponsored by University of Texas Southwestern Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 74 participants
- Enrollment target
- 2
- Study locations
Study Summary
Stereotactic radiation has been implemented more than 3 decades ago, initially to radiate benign and later malignant tumors within the brain. Doses up to 24 Gy in one session have been used. Hundreds of thousands of patients have been treated worldwide with very good outcomes . Over the last decade, the stereotactic radiation techniques have been implemented to treat extra-cranial tumors. The challenges of extra cranial tumors were in part target motion during the radiation session, but also accurate re positioning of the patient and of the target volume at time of radiation treatment. Specific immobilization devices are now available to improve accuracy of target localization. Stereotactic radiation therapy is widely available, non-invasive for the patient and less operator dependent as the planning process (from target volume to dose calculation) can be done and verified by different operators through a quality assessment procedure. Stereotactic radiation is a complex type of 3D CRT that is a very attractive technique making the 3D CRT more conformal and more accurate delivery of the prescription dose within the target volume with a very good sparing of surrounding normal tissue. The principles of stereotactic radiation are the following: precise image definition of target volume and OARs, very conformal radiation treatment.
Primary Outcome
To determine the 3 year patient overall global cosmesis score (on scale excellent, good, fair, or poor) and adverse cosmesis using SPBI with the GammPod using a 5 fraction escalated dose regimen (a more hypofractionated regimen compared to conventional APBI regimens). Cosmesis will be determined using patient cosmesis.
Conditions Studied
Interventions
- DEVICE Dose Fractionation
Study Locations (2)
Maryland
- University of Maryland Medical Center - Baltimore
Texas
- UT Southwestern Medical Centre - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2019-04-22 |
| Est. Completion | 2030-06-28 |
| Phase | NA |
What the registry record for NCT03581136 still lists
NCT03581136 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which Dose Fractionation is the first listed.
NCT03581136 reports a single indexed study location in Maryland, Texas.
Frequently Asked Questions
What is clinical trial NCT03581136 about?
NCT03581136 is a clinical study titled "Phase II Multi-center Trial Evaluating 5 Fraction Stereotactic Partial Breast Irradiation Using Gammapod". Stereotactic radiation has been implemented more than 3 decades ago, initially to radiate benign and later malignant tumors within the brain. Doses up to 24 Gy in one session have been used. Hundreds of thousands of patients have been treated worldwide with very good outcomes . Over the last decade,...
What is the current status of trial NCT03581136?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 74 participants. The study started on 2019-04-22. Estimated completion is 2030-06-28.
What conditions does trial NCT03581136 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT03581136?
The interventions under investigation include: Dose Fractionation (DEVICE).
Who is sponsoring clinical trial NCT03581136?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03581136 being conducted?
This trial has 2 study locations across Maryland, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT03581136's enrollment target sits among peer trials
74 682nd of 1224 higher than 542 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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