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NCT04403620 · ClinicalTrials.gov registry record · Phase 1
HYPORT: A Phase I/II Study of Hypofractionated Post-operative Radiation Therapy for Head and Neck Cancer
A Phase 1 study of Squamous Cell Carcinoma of Head and Neck, sponsored by University of Texas Southwestern Medical Center.
- Active
- Registry status
- Phase 1
- Development phase
- 59
- Enrollment target
- 1
- Study location
NCT04403620: Active Phase 1 study of Squamous Cell Carcinoma of Head and Neck, sponsored by University of Texas Southwestern Medical Center.
NCT04403620 is a Phase 1 study of Squamous Cell Carcinoma of Head and Neck that is active but no longer recruiting, run by University of Texas Southwestern Medical Center. The registered enrollment target is 59 participants, below the 169-participant average among 37 other Squamous Cell Carcinoma of Head and Neck trials with a reported enrollment target (65% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04403620, a Phase 1 study of Squamous Cell Carcinoma of Head and Neck, is active but no longer recruiting, sponsored by University of Texas Southwestern Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 59 participants
- Enrollment target
- 1
- Study location
Study Summary
There is a strong radiobiological and economic rationale for hypofractionated radiation therapy in head and neck cancer. Phase 1 of the trial aims to assess the acute toxicity and tolerability of hypofractionated radiation therapy in the post-operative setting, and to determine the dose/fractionation for Phase 2. Phase 2 aims to establish non-inferiority of swallowing-related quality of life and to assess the toxicity and efficacy of hypofractionated radiation therapy compared to conventionally fractionated radiation therapy in the post-operative setting.
Primary Outcome
Dose and fractionation to be used for Phase 2
Conditions Studied
Interventions
- RADIATION Intensity-modulated Radiation Therapy (IMRT)
Study Locations (1)
Texas
- University of Texas Southwestern Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2020-07-28 |
| Est. Completion | 2027-08 |
| Phase | Phase 1 |
What the registry record for NCT04403620 still lists
NCT04403620 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, below the 169-participant average among 37 other Squamous Cell Carcinoma of Head and Neck trials with a reported enrollment target (65% lower).
The record links to 1 condition, with Squamous Cell Carcinoma of Head and Neck appearing as the primary indexed condition, and to 1 intervention - of which Intensity-modulated Radiation Therapy (IMRT) is the first listed.
NCT04403620 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04403620 about?
NCT04403620 is a clinical study titled "HYPORT: A Phase I/II Study of Hypofractionated Post-operative Radiation Therapy for Head and Neck Cancer". There is a strong radiobiological and economic rationale for hypofractionated radiation therapy in head and neck cancer. Phase 1 of the trial aims to assess the acute toxicity and tolerability of hypofractionated radiation therapy in the post-operative setting, and to determine the dose/fractionatio...
What is the current status of trial NCT04403620?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 59 participants. The study started on 2020-07-28. Estimated completion is 2027-08.
What conditions does trial NCT04403620 study?
This clinical trial studies the following conditions: Squamous Cell Carcinoma of Head and Neck.
What interventions are being tested in trial NCT04403620?
The interventions under investigation include: Intensity-modulated Radiation Therapy (IMRT) (RADIATION).
Who is sponsoring clinical trial NCT04403620?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04403620 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04403620's enrollment target sits among peer trials
59 21st of 37 higher than 17 of 37 other Squamous Cell Carcinoma of Head and Neck trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Squamous Cell Carcinoma of Head and Neck trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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