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NCT01467115 · ClinicalTrials.gov registry record · Phase 2
Induction Chemotherapy Followed by Cetuximab and Radiation Therapy for Head and Neck Cancer
A Phase 2 study, sponsored by Drexel University College of Medicine.
- Completed
- Registry status
- Phase 2
- Development phase
- 1
- Enrollment target
NCT01467115: Completed Phase 2 study, sponsored by Drexel University College of Medicine.
NCT01467115 is a Phase 2 study that has completed, run by Drexel University College of Medicine. The registered enrollment target is 1 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01467115, a Phase 2 study, has completed, sponsored by Drexel University College of Medicine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 1 participants
- Enrollment target
Study Summary
More than 50% of Head and Neck cancers are locally advanced at presentation. Although surgery, in combination with other modalities like radiation therapy can achieve 40-50% five year survival rates, resection in the head and neck region can leave patients with poor functional and cosmetic outcomes. Due to these concerns about quality of life after surgery, there has been a lot of interest in non surgical alternatives of treatment. Various combinations of radiation, chemotherapy and biologics has showed promising results. However, questions still remain about the ideal combination treatment regimen. Based on assimilation of data from multiple sources, our study tries to identify the role of a potentially highly effective multi-modality regimen based on induction chemotherapy (Cisplatin, Docetaxel and 5 Fluorouracil) followed by combination of a biologic agent, Cetuximab, and radiation therapy.
Primary Outcome
to determine whether the intervention will prolong survival without needing salvage surgery (organ sparing survival)
Interventions
- BIOLOGICAL Cetuximab
- DRUG Leucovorin
- RADIATION Radiotherapy
- DRUG Filgrastim
- DRUG Erythropoetin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2010-03 |
| Est. Completion | 2014-10-07 |
| Phase | Phase 2 |
What the finished NCT01467115 record still lists
NCT01467115 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 5 interventions - of which Cetuximab is the first listed.
NCT01467115 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01467115 about?
NCT01467115 is a clinical study titled "Induction Chemotherapy Followed by Cetuximab and Radiation Therapy for Head and Neck Cancer". More than 50% of Head and Neck cancers are locally advanced at presentation. Although surgery, in combination with other modalities like radiation therapy can achieve 40-50% five year survival rates, resection in the head and neck region can leave patients with poor functional and cosmetic outcomes....
What is the current status of trial NCT01467115?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 1 participants. The study started on 2010-03. Estimated completion is 2014-10-07.
What interventions are being tested in trial NCT01467115?
The interventions under investigation include: Cetuximab (BIOLOGICAL), Leucovorin (DRUG), Radiotherapy (RADIATION), Filgrastim (DRUG), Erythropoetin (DRUG).
Who is sponsoring clinical trial NCT01467115?
This trial is sponsored by Drexel University College of Medicine, which has 25 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01467115's enrollment target sits among peer trials
1 2001st of 2000 the lowest 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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