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

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

ACRIN 6685 Overview

Protocol Overview

Schema

Aims

Hypotheses

Sample Size

Inclusion and Exclusion Criteria

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.

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.

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.

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).

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

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;

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

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

ACRIN 6685 Overview

Visit: www.acrin.org/6685_protocol.aspx

Contact:

Irene Mahon (215-574-3249; imahon@acr.org )

For more information: