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NCT02057107 · ClinicalTrials.gov registry record · Phase 2
SBRT With Cetuximab +/- Docetaxel Followed by Adjuvant Cetuximab +/- Docetaxel in Recurrent, Previously-Irradiated SCCHN
A Phase 2 study, sponsored by Heath Skinner.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
NCT02057107: Completed Phase 2 study, sponsored by Heath Skinner.
NCT02057107 is a Phase 2 study that has completed, run by Heath Skinner. The registered enrollment target is 40 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02057107, a Phase 2 study, has completed, sponsored by Heath Skinner.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
Study Summary
The aim of this trial is to examine the addition of docetaxel on disease progression, metastasis and survival of patients otherwise treated with SBRT and cetuximab alone. To better resolve the impact of the experimental treatment the presence/absence of prior cetuximab treatment will be determine before assigning treatment to either cetuximab and SBRT only or cetuximab, SBRT, and docetaxel.
Primary Outcome
The proportion of previously-irradiated patients treated with SBRT, cetuximab, and/or docetaxel, evaluated by PET/CT per RECIST Criteria v1.1 that do not experience locoregional disease progression within one year. Per RECIST, Progressive Disease is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s).
Interventions
- DRUG Docetaxel
- DRUG Cetuximab
- RADIATION SBRT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2013-07-03 |
| Est. Completion | 2019-12-31 |
| Phase | Phase 2 |
What the finished NCT02057107 record still lists
NCT02057107 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 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 3 interventions - of which Docetaxel is the first listed.
NCT02057107 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02057107 about?
NCT02057107 is a clinical study titled "SBRT With Cetuximab +/- Docetaxel Followed by Adjuvant Cetuximab +/- Docetaxel in Recurrent, Previously-Irradiated SCCHN". The aim of this trial is to examine the addition of docetaxel on disease progression, metastasis and survival of patients otherwise treated with SBRT and cetuximab alone. To better resolve the impact of the experimental treatment the presence/absence of prior cetuximab treatment will be determine be...
What is the current status of trial NCT02057107?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2013-07-03. Estimated completion is 2019-12-31.
What interventions are being tested in trial NCT02057107?
The interventions under investigation include: Docetaxel (DRUG), Cetuximab (DRUG), SBRT (RADIATION).
Who is sponsoring clinical trial NCT02057107?
This trial is sponsored by Heath Skinner, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02057107's enrollment target sits among peer trials
40 1362nd of 2000 higher than 542 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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