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NCT01349322 · ClinicalTrials.gov registry record · Phase 3
Higher Per Daily Treatment-Dose Radiation Therapy or Standard Per Daily Treatment Radiation Therapy in Treating Patients With Early-Stage Breast Cancer That Was Removed by Surgery
A Phase 3 study of Breast Cancer, sponsored by Radiation Therapy Oncology Group.
- Active
- Registry status
- Phase 3
- Development phase
- 2,354
- Enrollment target
- 20
- Study locations
NCT01349322: Active Phase 3 study of Breast Cancer, sponsored by Radiation Therapy Oncology Group.
NCT01349322 is a Phase 3 study of Breast Cancer that is active but no longer recruiting, run by Radiation Therapy Oncology Group. The registered enrollment target is 2,354 participants, below the 2,801-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (16% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01349322, a Phase 3 study of Breast Cancer, is active but no longer recruiting, sponsored by Radiation Therapy Oncology Group.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 2,354 participants
- Enrollment target
- 20
- Study locations
Study Summary
RATIONALE: It is not yet know whether higher per daily radiation therapy is equally as effective as standard per daily radiation therapy in treating breast cancer. PURPOSE: This randomized phase III trial studies how well an accelerated course of higher per daily radiation therapy with concomitant boost works compared to standard per daily radiation therapy with a sequential boost in treating patients with early-stage breast cancer that was removed by surgery.
Primary Outcome
In-breast recurrence (IBR) is defined as any of the following: invasive local recurrence-ipsilateral breast (within treatment field); invasive local recurrence-ipsilateral breast (outside treatment field); non-invasive local recurrence-ipsilateral breast (within treatment field); or non-invasive local recurrence-ipsilateral breast (outside treatment field). Time to IBR is defined as time from randomization to the date of first IBR, last known follow-up (censored), or death without IBR (competing
Conditions Studied
Interventions
- RADIATION Standard fractionation whole breast irradiation
- RADIATION Hypofractionated whole breast irradiation
- RADIATION Concurrent boost
- RADIATION Sequential boost
Study Locations (20)
California
- Sutter Cancer Centers Radiation Oncology Services-Auburn - Auburn
- Sutter Cancer Centers Radiation Oncology Services-Cameron Park - Cameron Park
- Mercy San Juan Medical Center - Carmichael
- Enloe Medical Center - Chico
- City of Hope Comprehensive Cancer Center - Duarte
- Epic Care-Dublin - Dublin
- 21st Century Oncology - El Segundo - El Segundo
- UC San Diego Moores Cancer Center - La Jolla
- Los Angeles County-USC Medical Center - Los Angeles
- USC / Norris Comprehensive Cancer Center - Los Angeles
- Cedars Sinai Medical Center - Los Angeles
- UCLA / Jonsson Comprehensive Cancer Center - Los Angeles
Arizona
- 21st Century Oncology-Scottsdale - Scottsdale
- Mayo Clinic in Arizona - Scottsdale
- Arizona Oncology Associates-West Orange Grove - Tucson
- Banner University Medical Center - Tucson - Tucson
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
- The Kirklin Clinic at Acton Road - Birmingham
Arkansas
- CHI Saint Vincent Cancer Center Hot Springs - Hot Springs
- University of Arkansas for Medical Sciences - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,354 participants |
| Start Date | 2011-05-24 |
| Phase | Phase 3 |
What the registry record for NCT01349322 still lists
NCT01349322 is an interventional study that assigns participants to a tested intervention. Its 2,354 participants enrollment target places it among the larger protocols in the corpus, below the 2,801-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (16% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 4 interventions - of which Standard fractionation whole breast irradiation is the first listed.
NCT01349322 names 20 study sites across 4 states, led by California, Arizona, Alabama.
Frequently Asked Questions
What is clinical trial NCT01349322 about?
NCT01349322 is a clinical study titled "Higher Per Daily Treatment-Dose Radiation Therapy or Standard Per Daily Treatment Radiation Therapy in Treating Patients With Early-Stage Breast Cancer That Was Removed by Surgery". RATIONALE: It is not yet know whether higher per daily radiation therapy is equally as effective as standard per daily radiation therapy in treating breast cancer. PURPOSE: This randomized phase III trial studies how well an accelerated course of higher per daily radiation therapy with concomitant ...
What is the current status of trial NCT01349322?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 2,354 participants. The study started on 2011-05-24.
What conditions does trial NCT01349322 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT01349322?
The interventions under investigation include: Standard fractionation whole breast irradiation (RADIATION), Hypofractionated whole breast irradiation (RADIATION), Concurrent boost (RADIATION), Sequential boost (RADIATION).
Who is sponsoring clinical trial NCT01349322?
This trial is sponsored by Radiation Therapy Oncology Group, which has 144 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01349322 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California. 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 NCT01349322's enrollment target sits among peer trials
2,354 62nd of 1224 higher than 1,163 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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