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Testing the Addition of the Anti-cancer Viral Therapy Telomelysin™ to Chemoradiation for Patients With Advanced Esophageal Cancer and Are Not Candidates for Surgery

StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Completion moved earlier from Oct 6, 2030 to Oct 6, 2029 Eligibility criteria expanded, about 40 words · Secondary endpoints: details revised at 2 of 4 entries · Study description revised Show 3 more changesShow less
    • Eligibility criteria expanded, about 40 words
    • Secondary endpoints: details revised at 2 of 4 entries
    • Study description revised
  2. Completion pushed from Oct 1, 2026 to Oct 6, 2030v31
  3. Study sites revised (17)v30 See this version in full on ClinicalTrials.gov ↗
  4. Completion date: Oct 1, 2025 to Oct 1, 2026v29
  5. Results first posted: May 29, 2025 Primary endpoint revised · Eligibility criteria expanded, about 14 words · Secondary endpoints revised (4)v28 Show 3 more changesShow less
    • Primary endpoint revised
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints revised (4)

    See this version in full on ClinicalTrials.gov ↗

Show 26 earlier versionsHide 26 earlier versions
  1. Re-verified, no change to tracked fieldsv27
  2. Primary completion date changed from estimate of Oct 1, 2024 to Oct 6, 2024v26
  3. Start date: Jun 29, 2020 to Dec 2, 2021 Trial status: Recruiting to Active, Not Recruiting · Site details revised at 17 of 17 sitesv25 Show 2 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 17 of 17 sites
  4. Study sites: 15 to 17v24
  5. Primary completion date: Oct 1, 2023 to Oct 1, 2024 Enrollment target: 21 to 16 · Completion date: Oct 1, 2024 to Oct 1, 2025v23 Show 2 more changesShow less
    • Enrollment target: 21 to 16
    • Completion date: Oct 1, 2024 to Oct 1, 2025
  6. Site details revised at 2 of 15 sitesv22
  7. Trial status: Active, Not Recruiting to Recruiting Enrollment target: 7 to 21 · Site details revised at 15 of 15 sitesv21 Show 2 more changesShow less
    • Enrollment target: 7 to 21
    • Site details revised at 15 of 15 sites
  8. Trial status: Suspended to Active, Not Recruiting Enrollment target: estimated 21 to confirmed 7v20 Show 1 more changeShow less
    • Enrollment target: estimated 21 to confirmed 7
  9. Trial status: Recruiting to Suspended Sponsor's reason: Scheduled Interim Monitoring Site details revised at 15 of 15 sitesv19 Show 1 more changeShow less
    • Site details revised at 15 of 15 sites
  10. Site details revised at 2 of 15 sitesv18
  11. Site details revised at 1 of 15 sitesv17
  12. Site details revised at 8 of 15 sitesv16
  13. Site details revised at 13 of 15 sitesv15
  14. Primary completion date: Oct 1, 2022 to Oct 1, 2023v14
  15. Study sites: 14 to 15v13
  16. Site details revised at 1 of 14 sitesv12
  17. Re-verified, no change to tracked fieldsv11
  18. Study sites: 13 to 14 Eligibility criteria expanded, about 31 wordsv10 Show 1 more changeShow less
    • Eligibility criteria expanded, about 31 words

    See this version in full on ClinicalTrials.gov ↗

  19. Study sites: 12 to 13v9
  20. Primary completion date: Oct 1, 2021 to Oct 1, 2022 Study sites: 8 to 12 · Completion date: Oct 1, 2023 to Oct 1, 2024v8 Show 2 more changesShow less
    • Study sites: 8 to 12
    • Completion date: Oct 1, 2023 to Oct 1, 2024
  21. Study sites: 1 to 8v7
  22. Site contact updatedv6
  23. Re-verified, no change to tracked fieldsv5
  24. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Jul 25, 2020 to Jun 29, 2020v4 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Jul 25, 2020 to Jun 29, 2020
  25. Re-verified, no change to tracked fieldsv3
  26. Secondary endpoints: details revised at 1 of 4 entries Study title revisedv2 Show 1 more changeShow less
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  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 phase I trial studies the side effects of OBP-301 when given together with carboplatin, paclitaxel, and radiation therapy in treating patients with esophageal or gastroesophageal cancer that invades local or regional structures. OBP-301 is a virus that has been designed to infect and destroy tumor cells (although there is a small risk that it can also infect normal cells). Chemotherapy drugs, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving OBP-301 with chemotherapy and radiation therapy may work better than standard chemotherapy and radiation therapy in treating patients with esophageal or gastroesophageal cancer.
Trial Details
NCT Number NCT04391049
Lead Sponsor NRG Oncology
Collaborators: National Cancer Institute (NCI)
Conditions Advanced Esophageal Adenocarcinoma, Advanced Gastroesophageal Junction Adenocarcinoma, Clinical Stage II Esophageal Adenocarcinoma AJCC v8, Clinical Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage IIA Esophageal Adenocarcinoma AJCC v8, Clinical Stage IIA Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage IIB Esophageal Adenocarcinoma AJCC v8, Clinical Stage IIB Gastroesophageal Junction Adenocarcinoma AJCC v8 +25 more
Enrollment 16 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov