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NCT02912312 · ClinicalTrials.gov registry record · Phase 2
Hypofractionated vs. Conventional Regional Nodal Radiation Therapy for Patients With Invasive Breast Cancer
A Phase 2 study of Invasive Breast Carcinoma and Stage II Breast Cancer AJCC v6 and v7, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 805
- Enrollment target
- 12
- Study locations
NCT02912312: Active Phase 2 study of Invasive Breast Carcinoma and Stage II Breast Cancer AJCC v6 and v7, sponsored by M.D. Anderson Cancer Center.
NCT02912312 is a Phase 2 study of Invasive Breast Carcinoma and Stage II Breast Cancer AJCC v6 and v7 that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 805 participants, above the 467-participant average among 45 other Invasive Breast Carcinoma trials with a reported enrollment target (72% higher). The trial reports 12 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02912312, a Phase 2 study of Invasive Breast Carcinoma and Stage II Breast Cancer AJCC v6 and v7, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 805 participants
- Enrollment target
- 12
- Study locations
Study Summary
To compare how often cancer recurs (comes back) after 3 weeks of radiation compared to 5 weeks of radiation in patients who receive radiation therapy delivered to the lymph nodes near the breast. The side effects that can develop during or after radiation treatment, including how often arm swelling (edema) happens, will also be studied.
Primary Outcome
Will compare between patients randomized to short versus standard regional nodal irradiation (RNI). Will use a two-sided chi-squared test with a significance level of 0.05.
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- OTHER Laboratory Biomarker Analysis
- OTHER Questionnaire Administration
- RADIATION Radiation Therapy
- RADIATION Hypofractionated Radiation Therapy
Study Locations (12)
Indiana
- Community MD Anderson Cancer Center East - Indianapolis
- Community MD Anderson Cancer Center South - Indianapolis
- Community MD Anderson Cancer Center North - Indianapolis
Florida
- Baptist - MD Anderson Cancer Center - Jacksonville
- Orlando Health Cancer Institute - Orlando
Texas
- M D Anderson Cancer Center - Houston
- UT Health San Antonio - MD Anderson Cancer Center - San Antonio
Arizona
- MD Anderson Cancer Center (Banner) - Gilbert
California
- Scripps- MD Anderson Cancer - San Diego
Colorado
- MD Anderson Cancer Center (Banner)- Northern Colorado - Greeley
New Jersey
- Cooper Hospital University Medical Center - Camden
Ohio
- Ohio Health - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 805 participants |
| Start Date | 2017-02-23 |
| Est. Completion | 2031-02-28 |
| Phase | Phase 2 |
What the registry record for NCT02912312 still lists
NCT02912312 is an interventional study that assigns participants to a tested intervention. The registered 805 participants enrollment target is mid-sized for trials with a published cap, above the 467-participant average among 45 other Invasive Breast Carcinoma trials with a reported enrollment target (72% higher).
The record links to 9 conditions, with Invasive Breast Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Quality-of-Life Assessment is the first listed.
NCT02912312 lists 12 locations in 8 states (Indiana, Florida, Texas).
Frequently Asked Questions
What is clinical trial NCT02912312 about?
NCT02912312 is a clinical study titled "Hypofractionated vs. Conventional Regional Nodal Radiation Therapy for Patients With Invasive Breast Cancer". To compare how often cancer recurs (comes back) after 3 weeks of radiation compared to 5 weeks of radiation in patients who receive radiation therapy delivered to the lymph nodes near the breast. The side effects that can develop during or after radiation treatment, including how often arm swelling ...
What is the current status of trial NCT02912312?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 805 participants. The study started on 2017-02-23. Estimated completion is 2031-02-28.
What conditions does trial NCT02912312 study?
This clinical trial studies the following conditions: Invasive Breast Carcinoma, Stage II Breast Cancer AJCC v6 and v7, Stage IIA Breast Cancer AJCC v6 and v7, Stage IIIC Breast Cancer AJCC v7, Stage IB Breast Cancer AJCC v7.
What interventions are being tested in trial NCT02912312?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Laboratory Biomarker Analysis (OTHER), Questionnaire Administration (OTHER), Radiation Therapy (RADIATION), Hypofractionated Radiation Therapy (RADIATION).
Who is sponsoring clinical trial NCT02912312?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02912312 being conducted?
This trial has 12 study locations across Arizona, California, Colorado, Florida, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Invasive Breast Carcinoma
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 NCT02912312's enrollment target sits among peer trials
805 10th of 45 higher than 36 of 45 other Invasive Breast Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Invasive Breast Carcinoma 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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