acrin 6685 overview acrin 6685 a multi-center trial of fdg-pet/ct staging of head and neck cancer...
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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 InvestigatorVal J. Lowe, M.D. Mayo Clinic
Surgical Co-InvestigatorBrendan C. Stack, Jr., M.D., F.A.C.S. University of Arkansas for Medical Sciences
QOL/CEA Co-InvestigatorChristopher 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
SchemaELIGIBILITY
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; [email protected] )
For more information: