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NCT00462735 · ClinicalTrials.gov registry record · Phase 2
Fluorouracil, Hydroxyurea, Cetuximab and Twice-daily Intensity Radiation Therapy for Advanced Head and Neck Cancer
A Phase 2 study, sponsored by Johnny Kao.
- Completed
- Registry status
- Phase 2
- Development phase
- 33
- Enrollment target
NCT00462735 is a Phase 2 study that has completed, run by Johnny Kao. The registered enrollment target is 33 participants.
The verdict
NCT00462735, a Phase 2 study, has completed, sponsored by Johnny Kao.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 33 participants
- Enrollment target
Study Summary
For advanced head and neck cancer, combined radiation and chemotherapy prevents recurrences and for many patients, improves survival. While combined cisplatin and radiation or cetuximab and radiation is more effective than radiation alone, approximately 50% of these patients will still recur. A more aggressive approach may be needed for these patients to prevent recurrence and death. The strategy of using multiple chemotherapy drugs with radiation given twice a day has been tested at Mount Sinai and University of Chicago. Approximately 80% of patients are cured with this strategy. While cure rates are higher than standard chemotherapy and radiation and the treatment is tolerable, side effects during treatment are common. We propose replacing a chemotherapy drug with a less toxic, targeted therapy called cetuximab. Our goal is to reduce toxicity while maintaining or improving cure rates for these patients.
Interventions
- DRUG Fluorouracil
- DRUG Hydroxyurea
- DRUG Cetuximab
- PROCEDURE radiotherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2007-02 |
| Est. Completion | 2010-10 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00462735
The ClinicalTrials.gov registry entry for NCT00462735 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johnny Kao, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Fluorouracil is the first listed.
NCT00462735 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00462735 about?
NCT00462735 is a clinical study titled "Fluorouracil, Hydroxyurea, Cetuximab and Twice-daily Intensity Radiation Therapy for Advanced Head and Neck Cancer". For advanced head and neck cancer, combined radiation and chemotherapy prevents recurrences and for many patients, improves survival. While combined cisplatin and radiation or cetuximab and radiation is more effective than radiation alone, approximately 50% of these patients will still recur. A more...
What is the current status of trial NCT00462735?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 33 participants. The study started on 2007-02. Estimated completion is 2010-10.
What interventions are being tested in trial NCT00462735?
The interventions under investigation include: Fluorouracil (DRUG), Hydroxyurea (DRUG), Cetuximab (DRUG), radiotherapy (PROCEDURE).
Who is sponsoring clinical trial NCT00462735?
This trial is sponsored by Johnny Kao, which has 2 total clinical trials registered on ClinicalTrials.gov.
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