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NCT04580446 · ClinicalTrials.gov registry record · Phase 1
HYHOPE: De-intensified Hypofractionated Radiation Therapy for HPV-associated Oropharynx Cancer
A Phase 1 study of Oropharyngeal Cancer and Human Papillomavirus-Related Carcinoma, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT04580446: Completed Phase 1 study of Oropharyngeal Cancer and Human Papillomavirus-Related Carcinoma, sponsored by University of Texas Southwestern Medical Center.
NCT04580446 is a Phase 1 study of Oropharyngeal Cancer and Human Papillomavirus-Related Carcinoma that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 24 participants, below the 189-participant average among 25 other Oropharyngeal Cancer trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04580446, a Phase 1 study of Oropharyngeal Cancer and Human Papillomavirus-Related Carcinoma, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a single arm Phase I study of de-intensified hypofractionated radiation therapy for favorable human papilloma virus-associated oropharynx cancer. It will evaluate the tolerability of a de-intensified hypofractionated radiation therapy regimen completed in 3 weeks (with equivalent biologically effective dose to 60 Gy in 30 fractions) with concurrent weekly cisplatin.
Primary Outcome
The number of participants experiencing dose-limiting toxicities (DLTs) will be used to determine the maximally tolerated dose (MTD) or optimal fractionation of hypofractionated radiation therapy. Level 0: 46.5 Gy in 15 fractions Level -1: 52 Gy in 20 fractions
Conditions Studied
Interventions
- RADIATION Hypofractionated intensity modulated radiotherapy
Study Locations (1)
Texas
- University of Texas Southwestern Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2020-12-03 |
| Est. Completion | 2024-12-20 |
| Phase | Phase 1 |
What the finished NCT04580446 record still lists
NCT04580446 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 189-participant average among 25 other Oropharyngeal Cancer trials with a reported enrollment target (87% lower).
The record links to 2 conditions, with Oropharyngeal Cancer appearing as the primary indexed condition, and to 1 intervention - of which Hypofractionated intensity modulated radiotherapy is the first listed.
NCT04580446 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04580446 about?
NCT04580446 is a clinical study titled "HYHOPE: De-intensified Hypofractionated Radiation Therapy for HPV-associated Oropharynx Cancer". This is a single arm Phase I study of de-intensified hypofractionated radiation therapy for favorable human papilloma virus-associated oropharynx cancer. It will evaluate the tolerability of a de-intensified hypofractionated radiation therapy regimen completed in 3 weeks (with equivalent biologicall...
What is the current status of trial NCT04580446?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2020-12-03. Estimated completion is 2024-12-20.
What conditions does trial NCT04580446 study?
This clinical trial studies the following conditions: Oropharyngeal Cancer, Human Papillomavirus-Related Carcinoma.
What interventions are being tested in trial NCT04580446?
The interventions under investigation include: Hypofractionated intensity modulated radiotherapy (RADIATION).
Who is sponsoring clinical trial NCT04580446?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04580446 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
Similar trials for Oropharyngeal Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04580446's enrollment target sits among peer trials
24 24th of 25 higher than 2 of 25 other Oropharyngeal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Oropharyngeal Cancer 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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