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Comparing Proton Therapy to Photon Radiation Therapy for Esophageal Cancer

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 4 years 10 months later Dec 21, 2026 → Nov 7, 2031
See other at-risk trials from NRG Oncology

Record History

  1. Primary completion pushed from Dec 21, 2026 to Nov 7, 2031 Completion pushed from Dec 21, 2031 to Nov 7, 2036v34 Show 1 more changeShow less
    • Completion pushed from Dec 21, 2031 to Nov 7, 2036
  2. Enrollment closed, study ongoing Site details revised at 96 of 96 sitesv33 Show 1 more changeShow less
    • Site details revised at 96 of 96 sites
  3. Study sites: 95 to 96v32
  4. Site details revised at 1 of 95 sitesv31
  5. Study sites revised (95)v30 See this version in full on ClinicalTrials.gov ↗
Show 28 earlier versionsHide 28 earlier versions
  1. Study sites: 92 to 95v29
  2. Start date: Mar 15, 2019 to Jun 26, 2019 Study sites: 90 to 92 · Interventions: 5FU (Drug), CAPOX regimen (Drug), Carboplatin (Drug), Docetaxel (Drug), Esophagectomy (Procedure), FOLFOX regimen (Drug)… to Biospecimen Collection (Procedure), Capecitabine (Drug), Carboplatin (Drug), Computed Tomography (Procedure), Docetaxel (Drug)… · Eligibility criteria expanded, about 12 words · 2 morev28 Show 5 more changesShow less
    • Study sites: 90 to 92
    • Interventions: 5FU (Drug), CAPOX regimen (Drug), Carboplatin (Drug), Docetaxel (Drug), Esophagectomy (Procedure), FOLFOX regimen (Drug)… to Biospecimen Collection (Procedure), Capecitabine (Drug), Carboplatin (Drug), Computed Tomography (Procedure), Docetaxel (Drug)…
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: 8 to 10
    • Study description expanded, about 55 words

    See this version in full on ClinicalTrials.gov ↗

  3. Site details revised at 2 of 90 sitesv27
  4. Study sites: 86 to 90v26
  5. Study sites: 84 to 86v25
  6. Study sites: 81 to 84v24
  7. Site details revised at 5 of 81 sitesv23
  8. Study sites: 77 to 81v22
  9. Site details revised at 2 of 77 sitesv21
  10. Study sites: 76 to 77v20
  11. Study sites: 65 to 76 Completion date: Feb 2032 to Dec 21, 2031v19 Show 1 more changeShow less
    • Completion date: Feb 2032 to Dec 21, 2031
  12. Primary completion date: Feb 1, 2027 to Dec 21, 2026v18
  13. Study sites: 62 to 65v17
  14. Study sites: 61 to 62v16
  15. Site details revised at 4 of 61 sitesv15
  16. Study sites: 53 to 61v14
  17. Study sites: 52 to 53v13
  18. Study sites: 48 to 52 Interventions: Carboplatin (Drug), Esophagectomy (Procedure), Intensity-Modulated Radiation Therapy (Radiation), Paclitaxel (Drug), Proton Beam Radiation… to 5FU (Drug), CAPOX regimen (Drug), Carboplatin (Drug), Docetaxel (Drug), Esophagectomy (Procedure), FOLFOX regimen (Drug)… · Eligibility criteria expanded, about 24 words · Study description expanded, about 51 wordsv12 Show 3 more changesShow less
    • Interventions: Carboplatin (Drug), Esophagectomy (Procedure), Intensity-Modulated Radiation Therapy (Radiation), Paclitaxel (Drug), Proton Beam Radiation… to 5FU (Drug), CAPOX regimen (Drug), Carboplatin (Drug), Docetaxel (Drug), Esophagectomy (Procedure), FOLFOX regimen (Drug)…
    • Eligibility criteria expanded, about 24 words
    • Study description expanded, about 51 words

    See this version in full on ClinicalTrials.gov ↗

  19. Study sites: 47 to 48v11
  20. Study sites: 45 to 47v10
  21. Study sites: 39 to 45v9
  22. Study sites: 36 to 39v8
  23. Study sites: 23 to 36v7
  24. Study sites: 21 to 23v6
  25. Study sites: 15 to 21v5
  26. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 15v4 Show 1 more changeShow less
    • Study sites: 0 to 15
  27. Re-verified, no change to tracked fieldsv3
  28. Start date: Feb 1, 2019 to Mar 15, 2019v2
  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.
NRG Oncology
67 trials monitored
See 5 trials at risk
Esophageal Cancer
1,012 trials monitored
See 53 trials at risk
This trial studies how well proton beam radiation therapy compared with intensity modulated photon radiotherapy works in treating patients with stage I-IVA esophageal cancer. Proton beam radiation therapy uses a beam of protons (rather than x-rays) to send radiation inside the body to the tumor without damaging much of the healthy tissue around it. Intensity modulated photon radiotherapy uses high-energy x-rays to deliver radiation directly to the tumor without damaging much of the healthy tissue around it. It is not yet known whether proton beam therapy or intensity modulated photon radiotherapy will work better in treating patients with esophageal cancer.
Trial Details
NCT Number NCT03801876
Lead Sponsor NRG Oncology
Collaborators: National Cancer Institute (NCI)
Conditions Clinical Stage I Esophageal Adenocarcinoma AJCC v8, Clinical Stage I Esophageal Squamous Cell Carcinoma AJCC v8, Clinical Stage I Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage II Esophageal Adenocarcinoma AJCC v8, Clinical Stage II Esophageal Squamous Cell Carcinoma AJCC v8, Clinical Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage III Esophageal Adenocarcinoma AJCC v8, Clinical Stage III Esophageal Squamous Cell Carcinoma AJCC v8 +5 more
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov