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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 is a Phase 2 study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 15 participants.
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.
Interventions
- DRUG Erlotinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2006-08 |
| Est. Completion | 2012-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00369512
The ClinicalTrials.gov registry entry for NCT00369512 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Erlotinib is the first listed.
NCT00369512 reports 0 study locations.
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.
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