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PIONEERNCT04846309

Hypoxia Imaging for Esophageal Cancer to Guide Personalized Radiation Therapy

StatusRecruiting
PhasePhase 1
Primary completion (estimated)

At risk: Primary completion moved at least 2 months later.

See at-risk trials from University of Utah

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Record History

All 12 versions: 10 with changes below, 2 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 24 words
    • Primary completion pushed from Oct 2026 to Jan 2027
    • Study completion pushed from Oct 2027 to Jan 2028
    • Publications: details revised at 36 of 37 entries
  2. Eligibility criteria revised
    • Primary completion date: Apr 2026 to Oct 2026
    • Study completion date: Apr 2027 to Oct 2027
    • Collaborators expanded, about 3 words
    v11
  3. Primary completion date: Apr 30, 2025 to Apr 2026
    • Study completion date: Apr 30, 2026 to Apr 2027
    v10
  4. Primary completion date: Apr 30, 2024 to Apr 30, 2025
    • Eligibility criteria expanded, about 6 words
    v9
  5. Site contact updatedv8
Show 4 earlier versionsHide 4 earlier versions
  1. Trial status: Suspended to Recruitingv5 Show 4 more changesShow less
    • Start date: Aug 12, 2021 to Oct 12, 2021
    • Primary completion date: Aug 1, 2024 to Apr 30, 2024
    • Study completion date: Aug 1, 2026 to Apr 30, 2026
    • Site details revised
  2. Trial status: Recruiting to Suspended Sponsor's reason: pending amendment
    • Site details revised
    v4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Aug 1, 2021 to Aug 12, 2021
    v3
  4. Secondary endpoints: details revised at 1 of 2 entriesv2
  1. Study First Submitted
  • Stopped: terminated, suspended or withdrawn
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

rate of grade ≥ 4 esophageal adverse events attributed to radiation therapy that occur within 30 days of finishing radiation therapy
Timeframe: 30 days after last study therapy
rate of grade ≥ 4 esophageal adverse events attributed to radiation therapy that occur within 84 days of finishing radiation therapy
Timeframe: 84 days after last study therapy
frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type, severity (as defined by the NIH CTCAE, version 5.0), seriousness, duration, and relationship to study treatment
Timeframe: 84 days after last study therapy

Secondary (2)

Progression-free survival (PFS)
Pathological complete response (pCR) rate

Arms and interventions

Treatment: all patientsExperimental

Radiation: Radiation

Drugs: FMISO PET CT

Sites

1 site in 1 country

  • Huntsman Cancer InstituteSalt Lake City, Utah, United States