Proton Beam Therapy in the Treatment of Esophageal Cancer

StatusTerminated
PhaseNot applicable
Started

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Record History

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  1. Trial terminated Sponsor's reason: The study is no longer relevant to have open to ensure insurance approval for this patient population
    • Study completion date changed from estimate of Aug 9, 2026 to Sep 9, 2026
    • Eligibility criteria shortened, about 17 words
  2. Re-verified, no change to tracked fieldsv19
  3. Results first posted: Apr 6, 2025v18
  4. Primary endpoints: 11 to 21v17
  5. Secondary endpoints: 4 to 2v16
Show 14 earlier versionsHide 14 earlier versions
  1. Primary endpoints revised (11)
    • Secondary endpoints revised (4)
    v15
  2. Phase: Phase 2 to Not applicablev14
  3. Primary completion date changed from estimate of Aug 31, 2022 to Sep 13, 2022v13
  4. Primary completion date: Aug 9, 2022 to Aug 31, 2022v12
  5. Primary completion date: Jul 31, 2024 to Aug 9, 2022v11 Show 5 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 40 to confirmed 22
    • Study completion date: Apr 30, 2028 to Aug 9, 2026
    • Secondary endpoints: details revised at 4 of 4 entries
    • Site details revised
  6. Primary completion date: Apr 30, 2022 to Jul 31, 2024
    • Study completion date: Apr 30, 2022 to Apr 30, 2028
    v10
  7. 3 versions Re-verified since Nov 14, 2019, no change to tracked fieldsv7-v9
  8. Eligibility criteria expanded, about 8 wordsv6
  9. Site contact updated
    • Eligibility criteria shortened, about 4 words
    v5
  10. Site contact updatedv4
  11. Re-verified, no change to tracked fieldsv3
  12. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Primary and study completion dates: May 31, 2022 to Apr 30, 2022
    • Start date changed from estimate of May 2018 to Apr 19, 2018
    • Site details revised
    • Eligibility criteria expanded, about 2 words
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The investigators plan to include both operable and inoperable patients with esophagus cancer in this prospective trial. Since both proton and photon treatments are biologically equivalent, the investigators do not expect a difference in tumor control compared to intensity modulated radiation therapy (IMRT). The investigators have a prospective experience of physician-reported toxicity and patient outcome using IMRT for patients with inoperable esophagus cancer that will serve as a comparison group. For the resectable patients receiving trimodality therapy (chemoradiation followed by surgery), the investigators will carefully track toxicity and patient outcomes prospectively. The central hypothesis is that the biologic efficacy for tumor control should be similar between protons and photons, and therefore survival measures should be similar between the two groups, but that the main difference lies in the total severe toxicities experienced by the patients undergoing therapy.
Trial Details
NCT Number NCT03482791
Lead Sponsor Washington University School of Medicine
Conditions
(from sponsor)		 Esophagus Cancer, Esophageal Cancer, Cancer of the Esophagus
Related terms Esophageal Neoplasms
Enrollment 22 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov