ACRIN PROTOCOL 6685 Minimize

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

Protocol Documents

Protocol-ACRIN 6685 Amendment 8 v06.29.2015 [PDF]

SOC-Protocol-ACRIN 6685 Amendment 8 v06.29.2015 [PDF]

Informed Consent-ACRIN 6685 v06.29.2015 [DOC]

Protocol-ACRIN 6685 Amendment 7 (SOC Cover Page), v2.26.2014 [PDF]

Informed Consent-ACRIN 6685 [DOC]

Principal Investigators:

Val J. Lowe, MD and Brendan C. Stack, Jr., MD, FACS

Status:  Open

Main Objective: The objective of this study is to determine the negative predictive value

of PET/CT for the N0 neck based upon pathologic sampling of the neck lymph nodes and to

determine PET/CT’s potential to change treatment of the N0 neck.

Participants: People with newly diagnosed head and neck squamous cell carcinoma being 

considered for surgical resection, with at least one side of the neck planned for dissection clinically

N0, and at risk for occult metastasis (when risk based on clinical data is felt to be greater than 30%).

Study Design Summary: A total of 292 participants will be enrolled from a minimum of

10 ACRIN-qualified institutions, enrolling for approximately 24 months.