ACRIN6685: FDG-PET/CT in Assessing the Tumor and Planning Neck Surgery in Patients With Newly Diagnosed H&N Cancer

Sponsor

American College of Radiology Imaging Network (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT00983697

Collaborator

National Cancer Institute (NCI) (NIH)

292

Enrollment

Locations

Arm

140

Anticipated Duration (Months)

24.3

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer	Procedure: therapeutic conventional surgery Radiation: fludeoxyglucose F 18	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

292 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

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

Actual Study Start Date :

Apr 1, 2010

Actual Primary Completion Date :

Jan 15, 2019

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: FDG PET/CT Planning for Therapeutic conventional surgery of the N0 neck is documented prior to and immediately after review of the fludeoxyglucose F 18 (FDG)-PET/CT scan completed per protocol.	Procedure: therapeutic conventional surgery Radiation: fludeoxyglucose F 18

Arm

Intervention/Treatment

Experimental: FDG PET/CT

Planning for Therapeutic conventional surgery of the N0 neck is documented prior to and immediately after review of the fludeoxyglucose F 18 (FDG)-PET/CT scan completed per protocol.

Procedure: therapeutic conventional surgery

Radiation: fludeoxyglucose F 18

Outcome Measures

Primary Outcome Measures

Negative predictive value of PET/CT imaging for staging the N0 neck based upon pathologic sampling of the neck lymph nodes [Within Two Weeks Before Surgery and after sampling of neck lymph nodes]
True negative cases will be determined by histopathology reports. The test will be defined as positive when SUVmax value of ≥ 2.0; and negative otherwise.

Secondary Outcome Measures

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 [Within Two Weeks Before Surgery and after sampling of neck lymph nodes]
True positive cases will be determined by histopathology reports. The test will be defined as positive when SUVmax value of ≥ 2.0; and negative otherwise. The diagnostic yield is defined as the ratio of cancers to total screened
Determine which factors (e.g., tumor size, secondary primary tumors, location, or intensity of FDG uptake) may identify patients who can forego neck dissection [Within Two Weeks Before Surgery and after sampling of neck lymph nodes]
True positive cases will be determined by histopathology reports. The test will be defined as positive when SUVmax value of ≥ 2.0; and negative otherwise. The diagnostic yield is defined as the ratio of cancers to total screened
Cost-effectiveness and cost-benefit of using PET/CT imaging for staging of head and neck cancer vs current good clinical practices [2 years post-surgery]
The outcome measure will use the total cost of care for each participant to compute the incremental cost-effectiveness ratio (ICER)
Incidence of occult distant body metastasis discovered by whole body PET/CT imaging [Within Two Weeks Before Surgery]
this outcome will count the distant body metastasis not previously seen and report the results as a percentage.
Correlation of PET/CT imaging findings with CT/MRI findings and biomarker results [Within Two Weeks Before Surgery]
the outcome measure will consist of paired proportions of dichotomized PET/CT and CT/MRI test results; and biomarker test results
Quality of life (QOL), particularly in patients whose management could have been altered by imaging results [2 years post-surgery]
QOL will be assessed using SF-36, Non-Utility HUI, and UW-QoL scores
Evaluation of the PET/CT imaging and biomarker data for complementary contributions to metastatic disease prediction [Within Two Weeks Before Surgery]
the metastatic disease status is the response variable and PET/CT test results and biomarker data are predictors.
Comparison of baseline PET/CT imaging and biomarker data with 2-year follow up as an adjunct assessment of their prediction of recurrence [2 years post-surgery]
model the associations of PET/CT test results and biomarker data (predictors) to recurrence
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 [2 years post-surgery]
model the associations of PET/CT test results and biomarker data (predictors) to disease-free survival
Comparison of baseline PET/CT imaging and biomarker data with 2-year follow up as an adjunct assessment of their prediction of overall survival [2 years post-surgery]
model the associations of PET/CT test results and biomarker data (predictors) to overall survival (censored responses)
Proportion of neck dissections that are extended based on local-reader PET/CT imaging findings shared with the surgeon before dissection [Within Two Weeks Before Surgery]
Outcome is defined as the number patients who surgeons intend to dissect levels beyond the initial surgery plan
Optimum cutoff value of standardized uptake values for diagnostic accuracy of PET/CT imaging [Within Two Weeks Before Surgery]
ROC analysis will be used to maximize the youden index and estimate the optimum cutoff value of SUV for diagnostic accuracy of PET/CT on N0 neck
Impact of PET/CT imaging on the N0 neck across different tumor subsites (defined by anatomic location) [Within Two Weeks Before Surgery]
Diagnostic Accuracy measures will be calculated using ROC analysis, subset by anatomic location

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arkansas Cancer Research Center at University of Arkansas for Medical Sciences	Little Rock	Arkansas	United States	72205
2	USC/Norris Comprehensive Cancer Center and Hospital	Los Angeles	California	United States	90089-9181
3	Morton Plant Mease Cancer Care at Mease Countryside Hospital	Safety Harbor	Florida	United States	34695
4	H. Lee Moffitt Cancer Center and Research Institute at University of South Florida	Tampa	Florida	United States	33612-9497
5	Jewish Hospital Heart and Lung Institute	Louisville	Kentucky	United States	40245
6	Mayo Clinic Cancer Center	Rochester	Minnesota	United States	55905
7	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis	Saint Louis	Missouri	United States	63110
8	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina	United States	27157
9	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104-4283
10	Kimmel Cancer Center at Thomas Jefferson University - Philadelphia	Philadelphia	Pennsylvania	United States	19107
11	Fox Chase Cancer Center - Philadelphia	Philadelphia	Pennsylvania	United States	19111-2497
12	Peking Union Medical College Hospital	Beijing		China	100730