Protocol Investigators

ACRIN 6685A Multi-center 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

Protocol Investigators Study Statistician Fenghai Duan, Ph.D. Center For Statistical Sciences Brown University • Protocol Investigator • Val J. Lowe, M.D. • Mayo Clinic • Surgical Co-Investigator • Brendan C. Stack, Jr., M.D., F.A.C.S. University of Arkansas for Medical Sciences • QOL/CEA Co-Investigator • Christopher S. Hollenbeak, Ph.D. • Depts. of Surgery and Public Health Sciences

Protocol Overview • Schema • Aims • Hypotheses • Sample Size • Inclusion and Exclusion Criteria

Study Aims Primary Aim Determine the negative predictive value of PET/CT for the N0 neck based upon pathologic sampling of the neck lymph nodes and determine PET/CT’s potential to change treatment of the N0 neck.

Study Hypotheses • PET/CT can more accurately identify head and neck cancer—or the absence thereof—at primary, nodal, or distant sites than clinical exam, CT, or MRI. • The additional PET/CT imaging information will lead to important changes in patient care, patient QoL, costs, and cost-effectiveness, specifically as relate to treatment of the N0 neck. These changes may result from: • upstaging an N0 neck to N+, • better defining extent of primary disease, or • uncovering unappreciated distant metastasis.

Study Hypotheses Other biomarkers may correspond to FDG-PET/CT findings, clinical stage, and patient outcomes. These findings may reflect the aggressiveness of the clinical course, which in turn may direct the patient towards more or less aggressive modality therapy.

Schema

Sample Size • A total of 292 participants. • A minimum of 10 ACRIN-approved institutions are expected to enroll participants for approximately 24 months.

Inclusion Criteria • Participant > 18 years of age; • Histologic confirmation of newly diagnosed SCC head and neck; • Unilateral or bilateral neck dissection planned for care (at least one clinically N0 neck side required); • CT and/or MR images taken within the four (4) weeks prior to enrollment which confirms head and neck SCC;

Inclusion Criteria cont. • At least one neck that is clinically N0 as defined by clinical exam (physical exam with CT and/or MRI as the gold standard of the N0 neck); • Stages T2, T3, or T4. N0–N3 • excluding N2c for bilateral disease • May be considered a viable clinical option to perform neck dissection when primary cancers are at high risk for neck metastasis

Exclusion Criteria • pregnant and/or breastfeeding • sinonasal carcinoma • tumors in the head and neck that are not SCC • salivary gland malignancies • thyroid cancers • advanced skin cancers • nasopharyngeal carcinoma • poorly controlled diabetes • not a candidate for surgery • weighs more than 350 lbs

For more information: Visit: www.acrin.org/6685_protocol.aspx Contact: Irene Mahon (215-574-3249; imahon@acr.org )

Protocol Investigators