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NCT01218048 · ClinicalTrials.gov registry record · Phase 2
ERBITUX® Followed by Adjuvant Treatment With Chemoradiation and ERBITUX® for Locally Advanced Head and Neck Squamous Cell Carcinoma
A Phase 2 study of Squamous Cell Carcinoma of the Head and Neck, sponsored by Robert Ferris.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT01218048: Completed Phase 2 study of Squamous Cell Carcinoma of the Head and Neck, sponsored by Robert Ferris.
NCT01218048 is a Phase 2 study of Squamous Cell Carcinoma of the Head and Neck that has completed, run by Robert Ferris. The registered enrollment target is 40 participants, below the 145-participant average among 29 other Squamous Cell Carcinoma of the Head and Neck trials with a reported enrollment target (72% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01218048, a Phase 2 study of Squamous Cell Carcinoma of the Head and Neck, has completed, sponsored by Robert Ferris.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
There are currently no useful tests to identify patients who will respond to cetuximab therapy, notably because EGFR levels do not correlate with the clinical responses observed. Thus, the investigators are investigating the role of cellular immunity and immune escape mechanisms to explain the differential clinical response to cetuximab.
Primary Outcome
Cetuximab-mediated NK cell activation (percentage of activity) measures at pre-/post-cetuximab exposure for patients in peripheral blood lymphocytes (PBL) and tumor infiltrating lymphocytes (TIL) and in those patients that did and did not respond to treatment.
Conditions Studied
Interventions
- DRUG Cetuximab
- PROCEDURE Surgery
- RADIATION Post-surgical radiation
- DRUG Cisplatin or carboplatin
Study Locations (1)
Pennsylvania
- UPCI - Hillman Cancer Center - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2011-02 |
| Est. Completion | 2017-02-14 |
| Phase | Phase 2 |
What the finished NCT01218048 record still lists
NCT01218048 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 145-participant average among 29 other Squamous Cell Carcinoma of the Head and Neck trials with a reported enrollment target (72% lower).
The record links to 1 condition, with Squamous Cell Carcinoma of the Head and Neck appearing as the primary indexed condition, and to 4 interventions - of which Cetuximab is the first listed.
NCT01218048 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT01218048 about?
NCT01218048 is a clinical study titled "ERBITUX® Followed by Adjuvant Treatment With Chemoradiation and ERBITUX® for Locally Advanced Head and Neck Squamous Cell Carcinoma". There are currently no useful tests to identify patients who will respond to cetuximab therapy, notably because EGFR levels do not correlate with the clinical responses observed. Thus, the investigators are investigating the role of cellular immunity and immune escape mechanisms to explain the diffe...
What is the current status of trial NCT01218048?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2011-02. Estimated completion is 2017-02-14.
What conditions does trial NCT01218048 study?
This clinical trial studies the following conditions: Squamous Cell Carcinoma of the Head and Neck.
What interventions are being tested in trial NCT01218048?
The interventions under investigation include: Cetuximab (DRUG), Surgery (PROCEDURE), Post-surgical radiation (RADIATION), Cisplatin or carboplatin (DRUG).
Who is sponsoring clinical trial NCT01218048?
This trial is sponsored by Robert Ferris, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01218048 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Squamous Cell Carcinoma of the Head and Neck
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01218048's enrollment target sits among peer trials
40 20th of 29 higher than 8 of 29 other Squamous Cell Carcinoma of the Head and Neck trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Squamous Cell Carcinoma of the Head and Neck 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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