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NCT02655068 · ClinicalTrials.gov registry record · Phase 3
Phase III Trial of PET/CT vs. CTSurveilance for Head and Neck Cancer
A Phase 3 study, sponsored by University of Pittsburgh.
- Terminated
- Registry status
- Phase 3
- Development phase
- 38
- Enrollment target
NCT02655068: Clinical Trial Phase 3 study, sponsored by University of Pittsburgh.
NCT02655068 is a Phase 3 study that was terminated before completion, run by University of Pittsburgh. The registered enrollment target is 38 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02655068, a Phase 3 study, was terminated before completion, sponsored by University of Pittsburgh.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 38 participants
- Enrollment target
Study Summary
The null hypothesis is that patients screened by PET/CT will not have detection of disease recurrence any earlier than those screened by CT alone. The alternative hypothesis is that PET/CT surveillance will lead to detection of disease recurrence 3 months earlier than CT surveillance. Furthermore, to reject the null hypothesis, earlier detection must be associated with a cause-specific survival improvement of 10%. Primary endpoints will include time from the completion of definitive therapy to diagnosis of recurrent disease, and absolute survival within 3 years after completion of initial therapy. Duration of survival between diagnosis of recurrence and subsequent death will not be a primary endpoint because the investigators expect that PET/CT will offer an opportunity for earlier recognition of recurrence and be subject to lead-time bias. Duration of survival will be measured from completion of primary treatment until death. Note: the presence of residual disease at surgical consolidation does not constitute a recurrence event.
Primary Outcome
All patients will be followed for disease recurrence for at least 3 years after completing primary treatment. The date of documented disease recurrence will be noted and the elapsed time from completion of definitive therapy (surgery or last day of radiotherapy) to recurrence will serve as the co-primary endpoint. A comparison of time to recurrence between the two arms will be conducted only with patients having a documented recurrence. The outcome will be measured using tumor measurements at ea
Interventions
- OTHER Computed Tomography (CT)
- OTHER PET/CT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2012-05 |
| Est. Completion | 2016-09-30 |
| Phase | Phase 3 |
Why NCT02655068 stopped before completion
NCT02655068 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Computed Tomography (CT) is the first listed.
NCT02655068 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02655068 about?
NCT02655068 is a clinical study titled "Phase III Trial of PET/CT vs. CTSurveilance for Head and Neck Cancer". The null hypothesis is that patients screened by PET/CT will not have detection of disease recurrence any earlier than those screened by CT alone. The alternative hypothesis is that PET/CT surveillance will lead to detection of disease recurrence 3 months earlier than CT surveillance. Furthermore, t...
What is the current status of trial NCT02655068?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 38 participants. The study started on 2012-05. Estimated completion is 2016-09-30.
What interventions are being tested in trial NCT02655068?
The interventions under investigation include: Computed Tomography (CT) (OTHER), PET/CT (OTHER).
Who is sponsoring clinical trial NCT02655068?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02655068's enrollment target sits among peer trials
38 1900th of 2000 higher than 100 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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