FDG-PET/CT in Assessing the Tumor and Planning Neck Surgery in Patients With Newly Diagnosed H&N Cancer

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIBiomarker/Laboratory analysis, Diagnostic, Health services researchActive18 and overNCI, OtherCDR0000654703
ACRIN-6685, CA80098, NCT00983697

Trial Description

Summary

RATIONALE: Diagnostic procedures, such as fludeoxyglucose F 18-PET/CT scan, may help doctors find head and neck cancer and find out how far the disease has spread. It may also help doctors plan the best treatment.

PURPOSE: This phase II trial is studying fludeoxyglucose F 18-PET/CT imaging to see how well it works in assessing the tumor and planning neck surgery in patients with newly diagnosed head and neck cancer.

Further Study Information

OBJECTIVES:

Primary

  • Determine the negative predictive value of PET/CT imaging based upon pathologic sampling of the neck lymph nodes in patients with head and neck cancer planning to undergo N0 neck surgery.
  • Determine the potential of PET/CT imaging to change treatment.

Secondary

  • Estimate the sensitivity and diagnostic yield of PET/CT imaging for detecting occult metastasis in the clinical N0 neck (both by neck and lymph node regions) or other local sites.
  • Determine the effect of other factors (e.g., tumor size, location, secondary primary tumors, or intensity of FDG uptake) that can lead to identification of subsets of patients that could potentially forego neck dissection or that can provide preliminary data for subsequent studies.
  • Compare the cost-effectiveness of using PET/CT imaging for staging head and neck cancer vs current good clinical practices.
  • Evaluate the incidence of occult distant body metastasis discovered by whole-body PET/CT imaging.
  • Correlate PET/CT imaging findings with CT/MRI findings and biomarker results.
  • Evaluate the quality of life of these patients, particularly of those patients whose management could have been altered by imaging results.
  • Evaluate PET/CT imaging and biomarker data for complementary contributions to metastatic disease prediction.
  • Compare baseline PET/CT imaging and biomarker data with 2-year follow up as an adjunct assessment of their prediction of recurrence, disease-free survival, and overall survival.
  • Determine the proportion of neck dissections that are extended (i.e., additional levels that clinicians intend to dissect beyond the initial surgery plan) based on local-reader PET/CT imaging findings shared with the surgeon before dissection.
  • Estimate the optimum cutoff value of standardized uptake values for diagnostic accuracy of PET/CT imaging.
  • Evaluate the impact of PET/CT imaging on the N0 neck across different tumor subsites (defined by anatomic location).

OUTLINE: This is a multicenter study.

Patients undergo fludeoxyglucose F 18-PET/CT imaging. Approximately 14 days later, patients undergo unilateral or bilateral neck dissection.

Patients complete quality-of-life questionnaires at baseline and at 1, 12, and 24 months after surgery.

Patients undergo blood and tissue sample collection periodically for biomarker analysis.

Patients are followed up periodically for up to 2 years after surgery.

Eligibility Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed newly diagnosed squamous cell carcinoma (SCC) of the head and neck , including any of the following sites:
  • Oral cavity
  • Oropharynx, including base of tongue and tonsils
  • Larynx
  • Supraglottis
  • Stage T2-T4, N0-N3 disease
  • Unilateral or bilateral neck dissection planned
  • No N2c disease (if bilateral disease is present)
  • Has ≥ 1 clinically N0 neck side as defined by clinical exam (physical exam with CT scan and/or MRI)
  • A N0 neck must be planned to be dissected for the patient to be eligible
  • . The N0 neck can be either ipsilateral to the head and neck tumor or the contralateral N0 neck if a bilateral neck dissection is planned
  • CT scan and/or MRI taken within the past 4 weeks to confirm SCC of the head and neck
  • Simultaneous diagnostic CT with PET scan allowed; however, PET cannot be used as part of the criteria to define the N0 neck disease
  • For CT scan and/or MR images from other institutions, ACRIN recommends a re-read by a local neuro-radiologist to ensure compliance
  • No sinonasal cancer, salivary gland cancer, thyroid cancer, nasopharyngeal cancer, or advanced skin cancer

PATIENT CHARACTERISTICS:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Weight ≤ 350 lbs
  • No poorly controlled diabetes (defined as fasting glucose level > 200 mg/dL) despite attempts to improve glucose control by fasting duration and adjustment of medications (optimally, patients will have glucose < 150 mg/dL)
  • No underlying medical condition that would preclude surgery (neck dissection)

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

Trial Contact Information

Trial Lead Organizations/Sponsors

American College of Radiology Imaging Network

  • National Cancer Institute
Val J. Lowe, Study Chair

Trial Sites

U.S.A.

Arkansas
Little Rock

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Brendan C. Stack
Ph: 501-686-8274

California
Duarte

City of Hope Comprehensive Cancer Center

Val J Lowe

Los Angeles

USC/Norris Comprehensive Cancer Center and Hospital

Val J Lowe

Florida
Dunedin

Morton Plant Mease

Val J Lowe

Jacksonville

University of Florida Health Science Center - Jacksonville

Barry M McCook
Ph: 888-254-7581

Tampa

H. Lee Moffitt Cancer Center and Research Institute at University of South Florida

Val J Lowe

Illinois
Springfield

Simmons Cooper Cancer Institute

Val J Lowe

Louisiana
Shreveport

Biomedical Research Foundation of Northwest Louisiana PET Imaging Center

Amol M Takalkar
Ph: 888-685-1152

Maryland
Baltimore

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Rathan Subramaniam
Ph: 410-955-8804
Email: jhcccro@jhmi.edu

Minnesota
Rochester

Mayo Clinic Cancer Center

Val J Lowe
Ph: 507-538-7623

Mississippi
Jackson

University of Mississippi Cancer Clinic

Andrew D Smith
Ph: 601-815-6700

Missouri
Saint Louis

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

Brian Nussenbaum
Ph: 800-600-3606
Email: info@siteman.wustl.edu

Springfield

St. John's Regional Health Center

Jay W Carlson
Ph: 800-821-7532

New York
New York

New York Weill Cornell Cancer Center at Cornell University

Val J Lowe

North Carolina
Winston-Salem

Wake Forest University Comprehensive Cancer Center

Val J Lowe

Oklahoma
Oklahoma City

Stephenson Cancer Center at the University of Oklahoma

Charles D Arnold
Ph: 405-271-4272
Email: julie-traylor@ouhsc.edu

Pennsylvania
Philadelphia

Fox Chase Cancer Center - Philadelphia

Jian Qin ( Yu
Ph: 215-728-4790

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

Charles M Intenzo
Ph: 215-955-6084

Val J Lowe

China

Beijing

Peking Union Medical College Hospital

Val J Lowe

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT00983697
ClinicalTrials.gov processed this data on April 09, 2015

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.