Clinical trial NCT00983697: FDG-PET/CT in Assessing the Tumor and Planning Neck Surgery in Patients With Newly Diagnosed H&N Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Head and Neck Cancer
Keywords: 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
Lead sponsor: American College of Radiology Imaging Network
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-09-24
Enrollment: 292
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Negative predictive value of PET/CT imaging for staging the N0 neck based upon pathologic sampling of the neck lymph nodes
timeFrame: Within Two Weeks Before Surgery and after sampling of neck lymph nodes
Secondary outcomes:
measure: Sensitivity and diagnostic yield of PET/CT imaging for detecting occult metastasis in the clinically N0 neck (both by neck and lymph node regions) or other local sites
timeFrame: Within Two Weeks Before Surgery and after sampling of neck lymph nodes
measure: Determine which factors (e.g., tumor size, secondary primary tumors, location, or intensity of FDG uptake) may identify patients who can forego neck dissection
timeFrame: Within Two Weeks Before Surgery and after sampling of neck lymph nodes
measure: Cost-effectiveness and cost-benefit of using PET/CT imaging for staging of head and neck cancer vs current good clinical practices
timeFrame: 2 years post-surgery
measure: Incidence of occult distant body metastasis discovered by whole body PET/CT imaging
timeFrame: Within Two Weeks Before Surgery
measure: Correlation of PET/CT imaging findings with CT/MRI findings and biomarker results
timeFrame: Within Two Weeks Before Surgery
measure: Quality of life (QOL), particularly in patients whose management could have been altered by imaging results
timeFrame: 2 years post-surgery
measure: Evaluation of the PET/CT imaging and biomarker data for complementary contributions to metastatic disease prediction
timeFrame: Within Two Weeks Before Surgery
measure: Comparison of baseline PET/CT imaging and biomarker data with 2-year follow up as an adjunct assessment of their prediction of recurrence
timeFrame: 2 years post-surgery
measure: Comparison of baseline PET/CT imaging and biomarker data with 2-year follow up as an adjunct assessment of their prediction of disease-free survival
timeFrame: 2 years post-surgery
measure: Comparison of baseline PET/CT imaging and biomarker data with 2-year follow up as an adjunct assessment of their prediction of overall survival
timeFrame: 2 years post-surgery
measure: Proportion of neck dissections that are extended based on local-reader PET/CT imaging findings shared with the surgeon before dissection
timeFrame: Within Two Weeks Before Surgery
measure: Optimum cutoff value of standardized uptake values for diagnostic accuracy of PET/CT imaging
timeFrame: Within Two Weeks Before Surgery
measure: Impact of PET/CT imaging on the N0 neck across different tumor subsites (defined by anatomic location)
timeFrame: Within Two Weeks Before Surgery
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
state: Arkansas
city: Los Angeles
country: United States
facility: USC/Norris Comprehensive Cancer Center and Hospital
state: California
city: Safety Harbor
country: United States
facility: Morton Plant Mease Cancer Care at Mease Countryside Hospital
state: Florida
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
state: Florida
city: Louisville
country: United States
facility: Jewish Hospital Heart and Lung Institute
state: Kentucky
city: Rochester
country: United States
facility: Mayo Clinic Cancer Center
state: Minnesota
city: Saint Louis
country: United States
facility: Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
state: Missouri
city: Winston-Salem
country: United States
facility: Wake Forest University Comprehensive Cancer Center
state: North Carolina
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center - Philadelphia
state: Pennsylvania
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
affiliation: Mayo Clinic
name: Val J. Lowe, MD
role: STUDY_CHAIR
References:
citation: Lowe VJ, Duan F, Subramaniam RM, Sicks JD, Romanoff J, Bartel T, Yu JQM, Nussenbaum B, Richmon J, Arnold CD, Cognetti D, Stack BC Jr. Multicenter Trial of [18F]fluorodeoxyglucose Positron Emission Tomography/Computed Tomography Staging of Head and Neck Cancer and Negative Predictive Value and Surgical Impact in the N0 Neck: Results From ACRIN 6685. J Clin Oncol. 2019 Jul 10;37(20):1704-1712. doi: 10.1200/JCO.18.01182. Epub 2019 Feb 15.