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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: Clinical Trial Phase 2 study, sponsored by Louisiana State University Health Sciences Center Shreveport.
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm.
Interventions
- DRUG Cetuximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2010-06 |
| Est. Completion | 2014-02 |
| Phase | Phase 2 |
Why NCT01326923 stopped before completion
NCT01326923 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Cetuximab is the first listed.
NCT01326923 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01326923's enrollment target sits among peer trials
7 1996th of 2000 higher than 5 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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