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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 is a Phase 3 study that was terminated before completion, run by University of Pittsburgh. The registered enrollment target is 38 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02655068
The ClinicalTrials.gov registry entry for NCT02655068 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pittsburgh, which has 1,238 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Computed Tomography (CT) is the first listed.
NCT02655068 reports 0 study locations.
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.
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