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The Quarterback Trial: Reduced Dose Radiotherapy for HPV+ Oropharynx Cancer

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Minor 2 versions Re-verified since Aug 5, 2024, no change to tracked fieldsv17-v18
  2. Minor Start date: Sep 2012 to Sep 1, 2012v16
  3. Notable Results first posted: Sep 1, 2022
    • Primary endpoint revised
    • Enrollment target: 20 to 23
    • Secondary endpoints: 4 to 9
    v15
  4. Minor Enrollment target: 24 to 20
    • Primary completion date changed from estimate of Dec 2021 to Apr 1, 2020
    • Study completion date: Dec 2021 to May 1, 2035
    • Secondary endpoints: details revised at 1 of 4 entries
    v14
  5. Minor 3 versions Re-verified since Mar 22, 2019, no change to tracked fieldsv11-v13
Show 9 earlier versionsHide 9 earlier versions
  1. Minor Interventions: Reduced Dose Radiation (Radiation), Standard Dose Radiation (Radiation) to Carboplatin (Drug), Reduced Dose Radiation (Radiation), Standard Dose Radiation (Radiation)v10
  2. Notable Enrollment target: estimated 365 to confirmed 24v9 Show 4 more changesShow less
    • Primary completion date: Jun 2019 to Dec 2021
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Jun 2021 to Dec 2021
    • Site details revised
  3. Minor Re-verified, no change to tracked fieldsv8
  4. Minor Study title expanded, about 7 wordsv7
  5. Minor Study sites: 2 to 1v6
  6. Minor Study description shortened, about 6 wordsv5
  7. Minor Eligibility criteria shortened, about 1 wordv4
  8. Minor Study sites: 1 to 2v3
  9. Minor Study description expanded, about 12 wordsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This trial aims to directly compare a reduced radiation dose to the standard of care in HPVOPC for non-inferiority, thus allowing for direct comparison of outcomes between the two groups. The study hypothesis is that LRC and PFS at 3 years for reduced dose CRT are non-inferior to standard dose CRT.
Trial Details
NCT Number NCT01706939
Lead Sponsor Icahn School of Medicine at Mount Sinai
Collaborators: Biodesign Institute, Arizona State University
Conditions
(from sponsor)
Squamous Cell Carcinomas
Related terms Carcinoma, Squamous Cell
Enrollment 23 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov