RAD 1802: Pilot Trial of Five Fraction Stereotactic Body Radiotherapy for Early Stage Breast Cancer Patients Eligible for Post-Operative Accelerated Partial Breast Irradiation (APBI)

StatusRecruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 1 year 11 months later Dec 2027 → Dec 1, 2029
See other at-risk trials from University of Alabama at Birmingham

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Dec 2027 to Dec 1, 2029 Show 5 more changesShow less
    • Study completion pushed from Dec 2028 to Dec 1, 2029
    • Study sites: 1 to 2
    • Secondary endpoints: details revised at 3 of 3 entries
    • Publications: details revised at 1 of 1 entry
    • Eligibility criteria shortened, about 2 words
  2. Re-verified, no change to tracked fieldsv17
  3. Trial status: Suspended to Recruiting
    • Primary completion date: Dec 2026 to Dec 2027
    • Study completion date: Dec 2027 to Dec 2028
    • Site details revised
    v16
  4. Trial status: Recruiting to Suspended Sponsor's reason: Pending software update and plans to reopen to accural once completev15 Show 4 more changesShow less
    • Primary completion date: Dec 2025 to Dec 2026
    • Study completion date: Dec 2026 to Dec 2027
    • Site details revised
    • Collaborators expanded, about 3 words
  5. Primary completion date: Dec 2024 to Dec 2025v14 Show 7 more changesShow less
    • Primary endpoint revised
    • Study completion date: Dec 2025 to Dec 2026
    • Interventions: 1-3 Fraction Stereotactic Body Radiation Therapy (Radiation) to 5 Fraction Stereotactic Body Radiation Therapy (Radiation)
    • Secondary endpoints: 2 to 3
    • Study title revised
    • Eligibility criteria shortened, about 2 words
    • Study description shortened, about 1 word
Show 12 earlier versionsHide 12 earlier versions
  1. Primary endpoint revised
    • Interventions: Single Fraction Stereotactic Body Radiation Therapy (Radiation) to 1-3 Fraction Stereotactic Body Radiation Therapy (Radiation)
    • Study description revised
    • Study title revised
    v13
  2. Primary completion date: Dec 2023 to Dec 2024
    • Study completion date: Dec 2023 to Dec 2025
    v12
  3. Enrollment target: 20 to 40v11 Show 5 more changesShow less
    • Primary and study completion dates: Dec 2021 to Dec 2023
    • Primary endpoint revised
    • Interventions: 5 Fraction Stereotactic Body Radiation Therapy (Radiation) to Single Fraction Stereotactic Body Radiation Therapy (Radiation)
    • Secondary endpoints: details revised at 1 of 2 entries
    • Study description expanded, about 2 words
  4. Re-verified, no change to tracked fieldsv10
  5. Start date changed from estimate of Sep 2019 to Aug 20, 2019v9
  6. Start date: Jul 2019 to Sep 2019
    • Eligibility criteria expanded, about 3 words
    v8
  7. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date: Jun 2019 to Jul 2019
    v7
  8. Primary and study completion dates: Dec 2020 to Dec 2021
    • Start date: Apr 2019 to Jun 2019
    v6
  9. Re-verified, no change to tracked fieldsv5
  10. Start date: Jan 2019 to Apr 2019v4
  11. Start date: Nov 2018 to Jan 2019v3
  12. Start date: Oct 2018 to Nov 2018v2
  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.
This study offers 5 fractions of radiation treatment through partial breast irradiation in patients with early stage breast cancer after having a lumpectomy.
Trial Details
NCT Number NCT03643861
Lead Sponsor University of Alabama at Birmingham
Collaborators: Varian Medical Systems
Conditions
(from sponsor)		 Breast Cancer
Related terms Breast Neoplasms
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov