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NCT01326923 · ClinicalTrials.gov registry record · Phase 2
Induction Chemo Then Concurrent Chemoradiotherapy With Cetuximab in Locally Advanced Head and Neck Squamous Cell Cancer
A Phase 2 study, sponsored by Louisiana State University Health Sciences Center Shreveport.
- Terminated
- Registry status
- Phase 2
- Development phase
- 7
- Enrollment target
NCT01326923 is a Phase 2 study that was terminated before completion, run by Louisiana State University Health Sciences Center Shreveport. The registered enrollment target is 7 participants.
The verdict
NCT01326923, a Phase 2 study, was terminated before completion, sponsored by Louisiana State University Health Sciences Center Shreveport.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 7 participants
- Enrollment target
Study Summary
This is an open label, single arm Phase II study of induction chemotherapy followed by concurrent chemo-radiotherapy in patients with locally advanced head and neck squamous cell cancer (HNSCC) using monoclonal antibody cetuximab. Those patients with locally advanced HNSCC deemed to be candidates for definitive concurrent chemo-radiotherapy will be treated initially with 6 weeks of PCC (Paclitaxel, cetuximab and Carboplatin). This will be followed by a week of no treatment for interim evaluation, followed by definitive concurrent chemo-radiotherapy using 70Gy radiation with weekly cetuximab and cisplatin for 7 weeks. The hypothesis of the study is that the use of cetuximab during induction chemotherapy followed by cetuximab concurrent with chemoradiotherapy using low dose weekly cisplatin will improve local control as well as distant spread.
Interventions
- DRUG Cetuximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2010-06 |
| Est. Completion | 2014-02 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01326923
The ClinicalTrials.gov registry entry for NCT01326923 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Louisiana State University Health Sciences Center Shreveport, which has 40 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Cetuximab is the first listed.
NCT01326923 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01326923 about?
NCT01326923 is a clinical study titled "Induction Chemo Then Concurrent Chemoradiotherapy With Cetuximab in Locally Advanced Head and Neck Squamous Cell Cancer". This is an open label, single arm Phase II study of induction chemotherapy followed by concurrent chemo-radiotherapy in patients with locally advanced head and neck squamous cell cancer (HNSCC) using monoclonal antibody cetuximab. Those patients with locally advanced HNSCC deemed to be candidates fo...
What is the current status of trial NCT01326923?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 7 participants. The study started on 2010-06. Estimated completion is 2014-02.
What interventions are being tested in trial NCT01326923?
The interventions under investigation include: Cetuximab (DRUG).
Who is sponsoring clinical trial NCT01326923?
This trial is sponsored by Louisiana State University Health Sciences Center Shreveport, which has 40 total clinical trials registered on ClinicalTrials.gov.
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