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Proton Therapy for Esophageal Cancer

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor 5 versions Re-verified since Feb 20, 2023, no change to tracked fieldsv16-v20
  2. Notable Primary completion date: Aug 2026 to Aug 2027
    • Start date: Jul 2012 to Feb 20, 2013
    • Study completion date: Aug 2028 to Aug 2032
    v15
  3. Notable Primary completion date: Aug 2024 to Aug 2026
    • Study completion date: Aug 2026 to Aug 2028
    v14
  4. Minor Re-verified, no change to tracked fieldsv13
  5. Notable Primary completion date: Aug 2022 to Aug 2024
    • Study completion date: Aug 2024 to Aug 2026
    v12
Show 10 earlier versionsHide 10 earlier versions
  1. Minor Re-verified, no change to tracked fieldsv11
  2. Notable Primary completion date: Aug 2018 to Aug 2022
    • Study completion date: Aug 2020 to Aug 2024
    v10
  3. Minor 3 versions Re-verified since Jul 31, 2016, no change to tracked fieldsv7-v9
  4. Notable Primary completion date: Aug 2017 to Aug 2018v6
  5. Minor Re-verified, no change to tracked fieldsv5
  6. Notable Primary completion date: Aug 2015 to Aug 2017
    • Study completion date: Aug 2016 to Aug 2020
    v4
  7. Minor Site contact updatedv3
  8. Minor Re-verified, no change to tracked fieldsv2
  1. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 goal of this phase II study is to investigate the feasibility, toxicity and efficacy of a regimen incorporating a proven systemic regimen, carboplatin /paclitaxel, with conformal proton modality, followed by definitive surgery. In most combined-modality trials to date, chemotherapy regimens have included cisplatin, usually in conjunction with 5-fluorouracil. In designing the regimen, the investigators attempt to improve on the standard cisplatin/5-fluorouracil regimen in several ways. First, full-dose paclitaxel is added to the regimen. This agent has activity against advanced esophageal cancer and is also a potent radiosensitizer. Second, the substitution of carboplatin for cisplatin has resulted in reduced toxicity of various combination regimens similar to that used by CROSS trial and allows for easier administration in the outpatient setting.4 Third, for localized esophageal cancer, dose distribution patterns achievable with proton beam could potentially offer important clinical advantages relative to those achievable with x-rays (photons).19 Based on this, the investigators believe that this study should be conducted with the radiation modality that offers the best dosimetry achievable at our institution.
Trial Details
NCT Number NCT01684904
Lead Sponsor Loma Linda University
Conditions
(from sponsor)
Esophagus Cancer
Related terms Esophageal Neoplasms
Enrollment 38 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov