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NCT05894083 · ClinicalTrials.gov registry record · Phase 2
A Phase II Study for p16+ Oropharyngeal Cancer PerSonalized De-escalation Treatment at University of MIchigan (CuSToMIze)
A Phase 2 study of Oropharyngeal Cancer and Squamous Cell Carcinoma of the Oropharynx, sponsored by University of Michigan Rogel Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 150
- Enrollment target
- 1
- Study location
NCT05894083: Recruiting Phase 2 study of Oropharyngeal Cancer and Squamous Cell Carcinoma of the Oropharynx, sponsored by University of Michigan Rogel Cancer Center.
NCT05894083 is a Phase 2 study of Oropharyngeal Cancer and Squamous Cell Carcinoma of the Oropharynx that is actively recruiting participants, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 150 participants, below the 184-participant average among 25 other Oropharyngeal Cancer trials with a reported enrollment target (18% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05894083, a Phase 2 study of Oropharyngeal Cancer and Squamous Cell Carcinoma of the Oropharynx, is actively recruiting participants, sponsored by University of Michigan Rogel Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 150 participants
- Enrollment target
- 1
- Study location
Study Summary
Single center, non-randomized Phase II study enrolling Stage I-II p16+ oropharyngeal cancer patients to one of two de-escalation treatment paradigms: (1) receive surgery followed by observation or risk-adjusted adjuvant radiation (+/-chemo), or (2) individualized adaptive definitive chemoradiation (CRT).
Primary Outcome
LR-RFS is defined as the difference between the date of the first treatment to the date of the first of the following events: death (any cause) or loco-regional progression. LR-RFS rates will be reported using Kaplan Meier (KM) estimates at 2 years.
Conditions Studied
Interventions
- OTHER Observation
- PROCEDURE Surgery
- COMBINATION_PRODUCT Chemoradiation
- RADIATION Post-operative radiation
Study Locations (1)
Michigan
- University of Michigan Rogel Cancer Center - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2023-04-27 |
| Est. Completion | 2030-12 |
| Phase | Phase 2 |
What NCT05894083 shows while recruiting
NCT05894083 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 184-participant average among 25 other Oropharyngeal Cancer trials with a reported enrollment target (18% lower).
The record links to 2 conditions, with Oropharyngeal Cancer appearing as the primary indexed condition, and to 4 interventions - of which Observation is the first listed.
NCT05894083 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT05894083 about?
NCT05894083 is a clinical study titled "A Phase II Study for p16+ Oropharyngeal Cancer PerSonalized De-escalation Treatment at University of MIchigan (CuSToMIze)". Single center, non-randomized Phase II study enrolling Stage I-II p16+ oropharyngeal cancer patients to one of two de-escalation treatment paradigms: (1) receive surgery followed by observation or risk-adjusted adjuvant radiation (+/-chemo), or (2) individualized adaptive definitive chemoradiation (...
What is the current status of trial NCT05894083?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2023-04-27. Estimated completion is 2030-12.
What conditions does trial NCT05894083 study?
This clinical trial studies the following conditions: Oropharyngeal Cancer, Squamous Cell Carcinoma of the Oropharynx.
What interventions are being tested in trial NCT05894083?
The interventions under investigation include: Observation (OTHER), Surgery (PROCEDURE), Chemoradiation (COMBINATION_PRODUCT), Post-operative radiation (RADIATION).
Who is sponsoring clinical trial NCT05894083?
This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05894083 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT05894083's enrollment target sits among peer trials
150 7th of 25 higher than 18 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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