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Accelerated Partial Breast Irradiation Following Lumpectomy for Breast Cancer

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv20
  2. Enrollment target: estimated 400 to confirmed 121v19
  3. 4 versions Re-verified since Oct 17, 2019, no change to tracked fieldsv15-v18
  4. Primary and study completion dates: Dec 2015 to Mar 2029 Primary endpoint revisedv14 Show all 2 changesShow less
    • Primary endpoint revised

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  5. Eligibility criteria shortened, about 16 wordsv13 Show moreShow less

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Show 11 earlier versionsHide 11 earlier versions
  1. Primary completion date: Nov 2008 to Dec 2015 Completion date: Nov 2009 to Dec 2015 · Interventions: Accelerated Partial Breast Irradiation (Device), Lumpectomy (Procedure) to Accelerated External Beam 3-D Conformal Radiotherapy (Radiation), Intra-Operative Radiotherapy (IORT) (Radiation), Intracavitary… · Study arms: 0 to 2v12 Show all 4 changesShow less
    • Completion date: Nov 2009 to Dec 2015
    • Interventions: Accelerated Partial Breast Irradiation (Device), Lumpectomy (Procedure) to Accelerated External Beam 3-D Conformal Radiotherapy (Radiation), Intra-Operative Radiotherapy (IORT) (Radiation), Intracavitary…
    • Study arms: 0 to 2
  2. Trial status: Recruiting to Active, Not Recruiting Primary completion date: Nov 2008 · Completion date: Nov 2009 · Eligibility criteria revised · 1 morev11 Show all 5 changesShow less
    • Primary completion date: Nov 2008
    • Completion date: Nov 2009
    • Eligibility criteria revised
    • Site details revised

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  3. Eligibility criteria revisedv10 Show moreShow less

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  4. Enrollment target: 100 to 400 Study description shortened, about 91 wordsv9 Show all 2 changesShow less
    • Study description shortened, about 91 words

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  5. Phase: Phase 2 to Not applicable Enrollment target: 50 to 100 · Eligibility criteria expanded, about 16 words · Study description expanded, about 91 words · 1 morev8 Show all 5 changesShow less
    • Enrollment target: 50 to 100
    • Eligibility criteria expanded, about 16 words
    • Study description expanded, about 91 words
    • Study site revised

    See this version in full on ClinicalTrials.gov ↗

  6. Eligibility criteria expanded, about 123 wordsv7 Show moreShow less

    See this version in full on ClinicalTrials.gov ↗

  7. 4 versions Re-verified since Jun 13, 2006, no change to tracked fieldsv3-v6
  8. Collaborators shortened, about 2 wordsv2 Show moreShow less

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
To determine whether an accelerated course of radiotherapy delivered to the lumpectomy cavity plus margin using IORT as a single dose, intracavitary brachytherapy with the MammoSite device over 5 days, partial breast 3-D CRT in 5 days, or stereotactic APBI over 4 days is a feasible and safe alternative to a six and a half week course of whole breast radiotherapy. The study will measure both short and long-term complications of radiation treatment, short and long-term breast cosmesis, local rates of in-breast cancer recurrence, regional recurrences, distant metastases, and overall survival.
Trial Details
NCT Number NCT00185744
Lead Sponsor Stanford University
Conditions Breast Cancer, Carcinoma, Ductal
Enrollment 121 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov