Accelerated Partial Breast Irradiation Following Lumpectomy for Breast Cancer

StatusActive, Not Recruiting
PhaseNot applicable
Started

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Record History

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  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 revised
    v14
  5. Eligibility criteria shortened, about 16 wordsv13
Show 11 earlier versionsHide 11 earlier versions
  1. Primary and study completion dates pushed 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
    v12
  2. Trial status: Recruiting to Active, Not Recruitingv11 Show 4 more changesShow less
    • Primary completion date: Nov 2008
    • Study completion date: Nov 2009
    • Eligibility criteria revised
    • Site details revised
  3. Eligibility criteria revisedv10
  4. Enrollment target: 100 to 400
    • Study description shortened, about 91 words
    v9
  5. Phase: Phase 2 to Not applicablev8 Show 4 more changesShow less
    • Enrollment target: 50 to 100
    • Eligibility criteria expanded, about 16 words
    • Study description expanded, about 91 words
    • Study site revised
  6. Eligibility criteria expanded, about 123 wordsv7
  7. 4 versions Re-verified since Jun 13, 2006, no change to tracked fieldsv3-v6
  8. Collaborators shortened, about 2 wordsv2
  1. Study First Submitted
  • 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
(from sponsor)		 Breast Cancer, Carcinoma, Ductal
Related terms Breast Neoplasms, Carcinoma, Ductal
Enrollment 121 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov