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NCT00369512 · ClinicalTrials.gov registry record · Phase 2
A Trial of Erlotinib + Radiotherapy for Cutaneous Squamous Cell Carcinoma
A Phase 2 study, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
NCT00369512: Completed Phase 2 study, sponsored by University of Alabama at Birmingham.
NCT00369512 is a Phase 2 study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 15 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00369512, a Phase 2 study, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
Study Summary
This is a phase II study designed to study the effectiveness of combined radiotherapy and erlotinib in the postoperative setting for patients with cutaneous SCC that are at high risk for recurrence. Participants enrolled in the study will be evaluated by a head and neck surgeon, and a radiation oncologist. Whenever possible, a preoperative biopsy will be performed after participant enrollment in the study for histological confirmation and for molecular correlates. Participants enrolled prior to surgical resection will begin erlotinib at 150 mg by mouth (PO) every day (QD) (14 tablets) to be taken 14 days prior to surgical resection. Following planned surgical resection, the participant will begin Erlotinib therapy and radiotherapy at the same time and within 4-8 weeks of the surgical resection.
Primary Outcome
Number of gradeable toxicities (via CTCAE manual) experienced by patients on this protocol--number of events
Interventions
- DRUG Erlotinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2006-08 |
| Est. Completion | 2012-09 |
| Phase | Phase 2 |
What the finished NCT00369512 record still lists
NCT00369512 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 1 intervention - of which Erlotinib is the first listed.
NCT00369512 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00369512 about?
NCT00369512 is a clinical study titled "A Trial of Erlotinib + Radiotherapy for Cutaneous Squamous Cell Carcinoma". This is a phase II study designed to study the effectiveness of combined radiotherapy and erlotinib in the postoperative setting for patients with cutaneous SCC that are at high risk for recurrence. Participants enrolled in the study will be evaluated by a head and neck surgeon, and a radiation onco...
What is the current status of trial NCT00369512?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2006-08. Estimated completion is 2012-09.
What interventions are being tested in trial NCT00369512?
The interventions under investigation include: Erlotinib (DRUG).
Who is sponsoring clinical trial NCT00369512?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00369512's enrollment target sits among peer trials
15 1919th of 2000 higher than 60 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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