FDG-PET/CT in Assessing the Tumor and Planning Neck Surgery in Patients With Newly Diagnosed H&N Cancer (ACRIN 6685)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by American College of Radiology Imaging Network
Sponsor:
Collaborator:
Information provided by (Responsible Party):
American College of Radiology Imaging Network
ClinicalTrials.gov Identifier:
NCT00983697
First received: September 23, 2009
Last updated: August 19, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Head and Neck Cancer
Other: laboratory biomarker analysis
Procedure: quality-of-life assessment
Procedure: therapeutic conventional surgery
Radiation: fludeoxyglucose F 18
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 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

Resource links provided by NLM:


Further study details as provided by American College of Radiology Imaging Network:

Primary Outcome Measures:
  • Negative predictive value of PET/CT imaging for staging the N0 neck based upon pathologic sampling of the neck lymph nodes [ Time Frame: Within Two Weeks Before Surgery ] [ Designated as safety issue: No ]
  • Potential of PET/CT imaging to change treatment of the N0 neck [ Time Frame: Within Two Weeks Before Surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sensitivity and diagnostic yield of PET/CT imaging for detecting occult metastasis in the clinically N0 neck (both by neck and lymph node regions) or other local sites [ Time Frame: Within Two Weeks Before Surgery ] [ Designated as safety issue: No ]
  • Effect of other factors (e.g., tumor size, location, second 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 subs ... [ Time Frame: Within Two Weeks Before Surgery ] [ Designated as safety issue: No ]
  • Cost-effectiveness and cost-benefit of using PET/CT imaging for staging of head and neck cancer vs current good clinical practices [ Time Frame: Within Two Weeks Before Surgery ] [ Designated as safety issue: No ]
  • Incidence of occult distant body metastasis discovered by whole body PET/CT imaging [ Time Frame: Within Two Weeks Before Surgery ] [ Designated as safety issue: No ]
  • Correlation of PET/CT imaging findings with CT/MRI findings and biomarker results [ Time Frame: Within Two Weeks Before Surgery ] [ Designated as safety issue: No ]
  • Quality of life, particularly in patients whose management could have been altered by imaging results [ Time Frame: Two Years ] [ Designated as safety issue: No ]
  • Evaluation of the PET/CT imaging and biomarker data for complementary contributions to metastatic disease prediction [ Time Frame: Within Two Weeks Before Surgery ] [ Designated as safety issue: No ]
  • Comparison of 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 [ Time Frame: Two Years ] [ Designated as safety issue: No ]
  • Proportion of neck dissections that are extended based on local-reader PET/CT imaging findings shared with the surgeon before dissection [ Time Frame: Within Two Weeks Before Surgery ] [ Designated as safety issue: No ]
  • Optimum cutoff value of standardized uptake values for diagnostic accuracy of PET/CT imaging [ Time Frame: Within Two Weeks Before Surgery ] [ Designated as safety issue: No ]
  • Impact of PET/CT imaging on the N0 neck across different tumor subsites (defined by anatomic location) [ Time Frame: Within Two Weeks Before Surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 292
Study Start Date: April 2010
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FDG PET/CT
Surgical planning for the N0 neck is documented prior to and immediately after review of the FDG-PET/CT scan completed per protocol.
Other: laboratory biomarker analysis Procedure: quality-of-life assessment Procedure: therapeutic conventional surgery Radiation: fludeoxyglucose F 18

Detailed Description:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00983697

Locations
United States, Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Brendan Stack, MD    501-686-5140      
United States, California
USC/Norris Comprehensive Cancer Center and Hospital Recruiting
Los Angeles, California, United States, 90089-9181
Contact: Clinical Trials Office - USC/Norris Comprehensive Cancer Cente    323-865-0451      
United States, Florida
Morton Plant Mease Cancer Care at Mease Countryside Hospital Recruiting
Safety Harbor, Florida, United States, 34695
Contact: Yair Safriel, MD    727-461-8885      
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida Recruiting
Tampa, Florida, United States, 33612-9497
Contact: Clinical Trials Office - H. Lee Moffitt Cancer Center and Rese    800-456-7121    canceranswers@moffitt.org   
United States, Kentucky
Jewish Hospital Heart and Lung Institute Recruiting
Louisville, Kentucky, United States, 40245
Contact: Robert Falk, MD    502-583-2731      
United States, Minnesota
Mayo Clinic Cancer Center Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Office - All Mayo Clinic Locations    507-538-7623      
United States, Missouri
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Farrokh Dehdashti, MD    314-747-1624      
United States, North Carolina
Wake Forest University Comprehensive Cancer Center Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Carol Geer, MD    336-716-4687      
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104-4283
Contact: Laurie Loevner, MD    215-662-7273      
Fox Chase Cancer Center - Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19111-2497
Contact: Clinical Trials Office - Fox Chase Cancer Center - Philadelphi    215-728-4790      
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Charles Intenzo, MD    215-955-8606      
China
Peking Union Medical College Hospital Recruiting
Beijing, China, 100730
Contact: Fang Li, MD    86-10-6529-5505      
Sponsors and Collaborators
American College of Radiology Imaging Network
Investigators
Study Chair: Val J. Lowe, MD Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: American College of Radiology Imaging Network
ClinicalTrials.gov Identifier: NCT00983697     History of Changes
Other Study ID Numbers: CDR0000654703, ACRIN-6685, CA80098
Study First Received: September 23, 2009
Last Updated: August 19, 2013
Health Authority: United States: NCI CIP

Keywords provided by American College of Radiology Imaging Network:
stage II squamous cell carcinoma of the larynx
stage II squamous cell carcinoma of the lip and oral cavity
stage II squamous cell carcinoma of the oropharynx
stage III squamous cell carcinoma of the larynx
stage III squamous cell carcinoma of the lip and oral cavity
stage III squamous cell carcinoma of the oropharynx
stage IV squamous cell carcinoma of the larynx
stage IV squamous cell carcinoma of the lip and oral cavity
stage IV squamous cell carcinoma of the oropharynx
stage II verrucous carcinoma of the oral cavity
stage III verrucous carcinoma of the oral cavity
stage IV verrucous carcinoma of the oral cavity
tongue cancer

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Fluorodeoxyglucose F18
Radiopharmaceuticals
Diagnostic Uses of Chemicals
Pharmacologic Actions
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 29, 2014