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NCT00468169 · ClinicalTrials.gov registry record · Phase 2
Cetuximab (ERBITUX®) Added to Two Concurrent Chemoradiotherapy Platforms in Locally Advanced Head and Neck Cancer
A Phase 2 study, sponsored by University of Chicago.
- Completed
- Registry status
- Phase 2
- Development phase
- 110
- Enrollment target
NCT00468169: Completed Phase 2 study, sponsored by University of Chicago.
NCT00468169 is a Phase 2 study that has completed, run by University of Chicago. The registered enrollment target is 110 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00468169, a Phase 2 study, has completed, sponsored by University of Chicago.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 110 participants
- Enrollment target
Study Summary
The main purpose of this study is to explore and compare the efficacy of Cetuximab (ERBITUX®) added to two concurrent chemoradiotherapy platforms of different intensity in locally advanced head and neck cancer.
Primary Outcome
Kaplan-Meier estimate of PFS at 1 years. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Interventions
- DRUG Cisplatin
- DRUG Hydroxyurea
- DRUG Cetuximab
- DRUG 5-FU
- RADIATION Twice-daily radiation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2006-07 |
| Est. Completion | 2012-11 |
| Phase | Phase 2 |
What the finished NCT00468169 record still lists
NCT00468169 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (17% lower).
The record links to 0 conditions, and to 5 interventions - of which Cisplatin is the first listed.
NCT00468169 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00468169 about?
NCT00468169 is a clinical study titled "Cetuximab (ERBITUX®) Added to Two Concurrent Chemoradiotherapy Platforms in Locally Advanced Head and Neck Cancer". The main purpose of this study is to explore and compare the efficacy of Cetuximab (ERBITUX®) added to two concurrent chemoradiotherapy platforms of different intensity in locally advanced head and neck cancer.
What is the current status of trial NCT00468169?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 110 participants. The study started on 2006-07. Estimated completion is 2012-11.
What interventions are being tested in trial NCT00468169?
The interventions under investigation include: Cisplatin (DRUG), Hydroxyurea (DRUG), Cetuximab (DRUG), 5-FU (DRUG), Twice-daily radiation (RADIATION).
Who is sponsoring clinical trial NCT00468169?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00468169's enrollment target sits among peer trials
110 632nd of 2000 higher than 1,361 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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