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ACRIN 6685 Overview ACRIN 6685 A 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
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ACRIN 6685 Overview Protocol Investigators 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 Study Statistician Fenghai Duan, Ph.D. Center For Statistical Sciences Brown University
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ACRIN 6685 Overview Protocol Overview Schema Aims Hypotheses Sample Size Inclusion and Exclusion Criteria
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ACRIN 6685 Overview 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.
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ACRIN 6685 Overview Study Hypotheses 1.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. 2.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.
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ACRIN 6685 Overview Study Hypotheses 3.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.
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ACRIN 6685 Overview Schema ELIGIBILITY Patients with newly diagnosed head and neck squamous cell carcinoma considered for surgical resection, with at least one side of the neck clinically N0. FDG-PET/CT Single FDG-PET/CT scan, including optional blood collection for biomarker assessment. FDG-PET/CT RESULTS REVIEW Surgeon reviews FDG-PET/CT images & reports - documents subsequent revisions to original surgical plans. SURGERY Per institutional standards. Pathology preparation follows, with reports to go to ACRIN. FOLLOW-UP Collection of health and health-related cost data as well as quality-of-life questionnaires (three follow-up time points).
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ACRIN 6685 Overview A total of 292 participants. A minimum of 10 ACRIN-approved institutions are expected to enroll participants for approximately 24 months. Sample Size
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ACRIN 6685 Overview 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;
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ACRIN 6685 Overview 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
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ACRIN 6685 Overview 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
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ACRIN 6685 Overview Visit: www.acrin.org/6685_protocol.aspx Contact: Irene Mahon (215-574-3249; imahon@acr.org )imahon@acr.org For more information:
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