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Phase III Trial of PET/CT vs. CTSurveilance for Head and Neck Cancer

NCT02655068 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2017-07-31

No results posted yet for this 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.

Conditions

  • Carcinoma, Squamous Cell of Head and Neck

Interventions

OTHER

PET/CT

Patients who undergo primary radiotherapy will have their first study imaging surveillance at 6 months (+/- 30 days) post radiotherapy. The Positron Emission Tomography - Computed Tomography (PET/CT)surveillance will continue at 9,12,18,24 months. During years 3-5, or long term follow up, surveillance with history and physical examination will occur every 6 months (+/- 30 days). The last protocol-specified imaging will occur at 24 months; during long term follow-up imaging will be conducted per the judgment of the treating physicians, as indicated by the history and physical examination findings.

OTHER

Computed Tomography (CT)

Patients who undergo primary surgery will have their first study imaging surveillance at 3 months (+/- 30 days) post-surgery. CT surveillance will continue at 6,9,12,18,24 months. During years 3-5, or long term follow up, surveillance with history and physical examination will occur every 6 months (+/- 30 days). The last protocol-specified imaging will occur at 24 months; during long term follow-up imaging will be conducted per the judgment of the treating physicians, as indicated by the history and physical examination findings

Sponsors & Collaborators

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Jonas Johnson · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2016-09-30
Completion
2016-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02655068 on ClinicalTrials.gov