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Intensity Modulated Radiotherapy (IMRT) vs. 3D-conformal Accelerated Partial Breast Irradiation (APBI) for Early Stage Breast Cancer After Lumpectomy

Study acronym: 2009-APBI
StatusRecruiting
PhasePhase 3
Started2009-07
View on ClinicalTrials.gov ↗
Record status
This record was last updated June 26, 2014 (before its estimated July 2018 completion). Its status may not reflect the trial's current state.

Amendment history

2014-06-24
Study Status, Outcome Measures, Contacts/Locations v5
Study sites4→5
Secondary endpoints7 entries, revised
Ipsilateral breast tumor recurrenceevent
2013-07-01
Study Status, Contacts/Locations v4
Study sitescontacts updated at 1 of 4 sites
2012-06-25
Study Status, Contacts/Locations v3
Re-verified, no change to tracked fields
2012-05-11
Study Status, Sponsor/Collaborators, Study Design v2
Enrollment target300→660
2011-03-09
Study Status, Eligibility, Contacts/Locations v1
Study sites5→4
Eligibility criteria-8 characters
[...] ng requirements and meet eligibility criteria as defined in protocol Sec. 4.4 (included below). Successful placement of fiducial markers for IGRT requirin [...]
2010-08-18
Original filing
In the setting of radiotherapy as part of breast-conservation therapy for patients with early stage breast cancer, the novel planning and delivery method of intensity modulated radiotherapy is an effective and safe alternative to the commonly-used standard 3D-conformal external beam radiotherapy, spares more normal breast and lung tissue, and may lead to improved clinical outcomes.
Trial Details
NCT Number NCT01185132
Lead Sponsor Rocky Mountain Cancer Centers
Conditions Breast Cancer
Enrollment 660 participants
Start Date 2009-07
Primary Completion 2018-07 (estimated)
Study Completion 2028-07 (estimated)
Updated on ClinicalTrials.gov 2014-06-26