FDG-PET/CT in Assessing the Tumor and Planning Neck Surgery in Patients With Newly Diagnosed H&N Cancer



Status:Active, not recruiting
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:10/13/2018
Start Date:April 2010
End Date:December 2019

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A Multicenter Trial of FDG-PET/CT Staging of Head and Neck Cancer and Its Impact on the N0 Neck Surgical Treatment in Head and Neck Cancer Patients

RATIONALE: Diagnostic procedures, such as fludeoxyglucose F 18-PET/CT scan, may help doctors
find head and neck cancer and find out how far the disease has spread. It may also help
doctors plan the best treatment.

PURPOSE: This phase II trial is studying fludeoxyglucose F 18-PET/CT imaging to see how well
it works in assessing the tumor and planning neck surgery in patients with newly diagnosed
head and neck cancer.

OBJECTIVES:

Primary

- Determine the negative predictive value of PET/CT imaging based upon pathologic sampling
of the neck lymph nodes in patients with head and neck cancer planning to undergo N0
neck surgery.

- Determine the potential of PET/CT imaging to change treatment.

Secondary

- Estimate the sensitivity and diagnostic yield of PET/CT imaging for detecting occult
metastasis in the clinical N0 neck (both by neck and lymph node regions) or other local
sites.

- Determine the effect of other factors (e.g., tumor size, location, secondary primary
tumors, or intensity of FDG uptake) that can lead to identification of subsets of
patients that could potentially forego neck dissection or that can provide preliminary
data for subsequent studies.

- Compare the cost-effectiveness of using PET/CT imaging for staging head and neck cancer
vs current good clinical practices.

- Evaluate the incidence of occult distant body metastasis discovered by whole-body PET/CT
imaging.

- Correlate PET/CT imaging findings with CT/MRI findings and biomarker results.

- Evaluate the quality of life of these patients, particularly of those patients whose
management could have been altered by imaging results.

- Evaluate PET/CT imaging and biomarker data for complementary contributions to metastatic
disease prediction.

- Compare baseline PET/CT imaging and biomarker data with 2-year follow up as an adjunct
assessment of their prediction of recurrence, disease-free survival, and overall
survival.

- Determine the proportion of neck dissections that are extended (i.e., additional levels
that clinicians intend to dissect beyond the initial surgery plan) based on local-reader
PET/CT imaging findings shared with the surgeon before dissection.

- Estimate the optimum cutoff value of standardized uptake values for diagnostic accuracy
of PET/CT imaging.

- Evaluate the impact of PET/CT imaging on the N0 neck across different tumor subsites
(defined by anatomic location).

OUTLINE: This is a multicenter study.

Patients undergo fludeoxyglucose F 18-PET/CT imaging. Approximately 14 days later, patients
undergo unilateral or bilateral neck dissection.

Patients complete quality-of-life questionnaires at baseline and at 1, 12, and 24 months
after surgery.

Patients undergo blood and tissue sample collection periodically for biomarker analysis.

Patients are followed up periodically for up to 2 years after surgery.

DISEASE CHARACTERISTICS:

- Histologically confirmed newly diagnosed squamous cell carcinoma (SCC) of the head and
neck , including any of the following sites:

- Oral cavity

- Oropharynx, including base of tongue and tonsils

- Larynx

- Supraglottis

- Stage T2-T4, N0-N3 disease

- Unilateral or bilateral neck dissection planned

- No N2c disease (if bilateral disease is present)

- Has ≥ 1 clinically N0 neck side as defined by clinical exam (physical exam with
CT scan and/or MRI)

- A N0 neck must be planned to be dissected for the patient to be eligible

- . The N0 neck can be either ipsilateral to the head and neck tumor or the
contralateral N0 neck if a bilateral neck dissection is planned

- CT scan and/or MRI taken within the past 4 weeks to confirm SCC of the head and neck

- Simultaneous diagnostic CT with PET scan allowed; however, PET cannot be used as
part of the criteria to define the N0 neck disease

- For CT scan and/or MR images from other institutions, ACRIN recommends a re-read
by a local neuro-radiologist to ensure compliance

- No sinonasal cancer, salivary gland cancer, thyroid cancer, nasopharyngeal cancer, or
advanced skin cancer

PATIENT CHARACTERISTICS:

- Not pregnant or nursing

- Negative pregnancy test

- Weight ≤ 350 lbs

- No poorly controlled diabetes (defined as fasting glucose level > 200 mg/dL) despite
attempts to improve glucose control by fasting duration and adjustment of medications
(optimally, patients will have glucose < 150 mg/dL)

- No underlying medical condition that would preclude surgery (neck dissection)

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics
We found this trial at
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4018 W Capitol Ave.
Little Rock, Arkansas 72205
(501) 296-1200
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences The Winthrop P. Rockefeller...
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4117 East Fowler Avenue
Tampa, Florida 33612
(813) 745-4673
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida Moffitt Cancer...
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1 Medical Center Blvd
Winston-Salem, North Carolina 27103
(336) 716-2011
Wake Forest University Comprehensive Cancer Center Our newly expanded Comprehensive Cancer Center is the region’s...
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Winston-Salem, NC
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Beijing,
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Louisville, Kentucky 40245
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Philadelphia, Pennsylvania 19111
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3400 Civic Center Blvd
Philadelphia, Pennsylvania 19104
(215) 662-6065
Abramson Cancer Center of the University of Pennsylvania The Abramson Cancer Center of the University...
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111 S 11th St,
Philadelphia, Pennsylvania 19107
(877) 503-8350
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia The Kimmel Cancer Center at Jefferson...
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Cancer Center The Mayo Clinic Cancer Center is a National Cancer Institute-designated comprehensive...
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Rochester, MN
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Safety Harbor, FL
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