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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer

Thank you

Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Negative predictive value of PET/CT imaging for staging the N0 neck based upon pathologic sampling of the neck lymph nodes

Outcome Time Frame:

Within Two Weeks Before Surgery

Safety Issue:

No

Principal Investigator

Val J. Lowe, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: NCI CIP

Study ID:

CDR0000654703

NCT ID:

NCT00983697

Start Date:

April 2010

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • stage II squamous cell carcinoma of the larynx
  • stage II squamous cell carcinoma of the lip and oral cavity
  • stage II squamous cell carcinoma of the oropharynx
  • stage III squamous cell carcinoma of the larynx
  • stage III squamous cell carcinoma of the lip and oral cavity
  • stage III squamous cell carcinoma of the oropharynx
  • stage IV squamous cell carcinoma of the larynx
  • stage IV squamous cell carcinoma of the lip and oral cavity
  • stage IV squamous cell carcinoma of the oropharynx
  • stage II verrucous carcinoma of the oral cavity
  • stage III verrucous carcinoma of the oral cavity
  • stage IV verrucous carcinoma of the oral cavity
  • tongue cancer
  • Head and Neck Neoplasms

Name

Location

Mayo Clinic Cancer CenterRochester, Minnesota  55905
Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283
Kimmel Cancer Center at Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
Siteman Cancer Center at Barnes-Jewish Hospital - Saint LouisSt. Louis, Missouri  63110
Fox Chase Cancer Center - PhiladelphiaPhiladelphia, Pennsylvania  19111-2497
H. Lee Moffitt Cancer Center and Research Institute at University of South FloridaTampa, Florida  33612
Morton Plant Mease Cancer Care at Mease Countryside HospitalSafety Harbor, Florida  34695
Jewish Hospital Heart and Lung InstituteLouisville, Kentucky  40245