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NCT05540899 · ClinicalTrials.gov registry record · Phase 1
Testing the Safety of Giving a Standard Dose of Radiation Over a Shorter Period of Time for Patients Who Had Surgery for Intermediate-Risk Head and Neck Cancer
A Phase 1 study of Head and Neck Cancer and Head and Neck Squamous Cell Carcinoma, sponsored by American College of Radiology.
- Active
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
- 1
- Study location
NCT05540899: Active Phase 1 study of Head and Neck Cancer and Head and Neck Squamous Cell Carcinoma, sponsored by American College of Radiology.
NCT05540899 is a Phase 1 study of Head and Neck Cancer and Head and Neck Squamous Cell Carcinoma that is active but no longer recruiting, run by American College of Radiology. The registered enrollment target is 14 participants, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05540899, a Phase 1 study of Head and Neck Cancer and Head and Neck Squamous Cell Carcinoma, is active but no longer recruiting, sponsored by American College of Radiology.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial is looking to determine if hypofractionated radiation therapy can be given safely after surgery for intermediate-risk head and neck cancer.
Primary Outcome
All grades are based on Common Terminology Criteria for Adverse Events (CTCAE v.5). H-PORT in this population will be deemed safe if 0-2 patients out of the first 12 evaluable patients experience DLTs. Should 3 or more patients experience DLTs at any time point during the DLT evaluation period, then accrual to the trial will be stopped, if applicable. Once 12 evaluable eligible patients have completed their DLT assessment, the rate of unacceptable DLTs and 95% confidence interval will be summar
Conditions Studied
Interventions
- RADIATION Hypofractionated Postoperative Radiotherapy
Study Locations (1)
Pennsylvania
- Milton S. Hershey Medical Center - Hershey
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2023-11-08 |
| Est. Completion | 2028-11 |
| Phase | Phase 1 |
What the registry record for NCT05540899 still lists
NCT05540899 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (95% lower).
The record links to 5 conditions, with Head and Neck Cancer appearing as the primary indexed condition, and to 1 intervention - of which Hypofractionated Postoperative Radiotherapy is the first listed.
NCT05540899 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05540899 about?
NCT05540899 is a clinical study titled "Testing the Safety of Giving a Standard Dose of Radiation Over a Shorter Period of Time for Patients Who Had Surgery for Intermediate-Risk Head and Neck Cancer". This phase I trial is looking to determine if hypofractionated radiation therapy can be given safely after surgery for intermediate-risk head and neck cancer.
What is the current status of trial NCT05540899?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2023-11-08. Estimated completion is 2028-11.
What conditions does trial NCT05540899 study?
This clinical trial studies the following conditions: Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma, Squamous Cell Carcinoma of the Oropharynx, Squamous Cell Carcinoma of the Oral Cavity, Squamous Cell Carcinoma of the Larynx.
What interventions are being tested in trial NCT05540899?
The interventions under investigation include: Hypofractionated Postoperative Radiotherapy (RADIATION).
Who is sponsoring clinical trial NCT05540899?
This trial is sponsored by American College of Radiology, which has 14 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05540899 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Head and Neck 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 NCT05540899's enrollment target sits among peer trials
14 230th of 250 higher than 21 of 250 other Head and Neck Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Head and Neck 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.
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