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Propranolol With Standard Chemoradiation for Esophageal Adenocarcinoma

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Primary and study completion dates: Apr 1, 2027 to Apr 1, 2029
    • Study description expanded, about 4 words
    v12
  2. Re-verified, no change to tracked fieldsv11
  3. Eligibility criteria expanded, about 3 wordsv10
  4. Enrollment target: 60 to 106
    • Primary and study completion dates: Apr 1, 2026 to Apr 1, 2027
    v9
  5. Primary completion date: Apr 1, 2023 to Apr 1, 2026
    • Study completion date: Apr 1, 2024 to Apr 1, 2026
    v8
Show 6 earlier versionsHide 6 earlier versions
  1. Re-verified, no change to tracked fieldsv7
  2. Eligibility criteria expanded, about 2 wordsv6
  3. Eligibility criteria shortened, about 3 wordsv5
  4. Trial status: Not Yet Recruiting to Recruitingv4 Show 5 more changesShow less
    • Study sites: 0 to 1
    • Primary completion date: Feb 28, 2023 to Apr 1, 2023
    • Study completion date: Feb 28, 2024 to Apr 1, 2024
    • Start date changed from estimate of Feb 28, 2021 to Apr 1, 2021
    • Eligibility criteria expanded, about 25 words
  5. Start date: Dec 30, 2020 to Feb 28, 2021
    • Primary completion date: Dec 30, 2022 to Feb 28, 2023
    • Study completion date: Dec 30, 2023 to Feb 28, 2024
    v3
  6. Interventions: Chemoradiation (Drug), Propanolol + CRT (Drug), Propranolol (Drug) to 3 Dimensional Conformal Radiation Therapy (Radiation), Carboplatin (Drug), Intensity Modulated Radiation Therapy (Radiation), Paclitaxel…
    • Study description expanded, about 41 words
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 phase II trial studies the side effects and best dose of propranolol when administered concurrently with SOC neoadjuvant CRT in patients with esophageal carcinoma, with a safety lead-in and dose expansion cohort. Patients who are already on β-blockers will receive standard of care CRT, or definitive chemotherapy or chemotherapy-immunotherapy and will be considered separately as a single arm prospective cohort
Trial Details
NCT Number NCT04682158
Lead Sponsor Roswell Park Cancer Institute
Conditions
(from sponsor)		 Esophageal Adenocarcinoma
Related terms Adenocarcinoma Of Esophagus
Enrollment 106 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov