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OpenTrials
Completed

NCT Number: NCT00388024

PET Scans and CT Scans in Patients With Locally Advanced Head and Neck Cancer Undergoing Chemotherapy and Radiation Therapy

RATIONALE: Imaging procedures, such as PET scan and CT scan, may help doctors predict a patient's response to treatment and plan the best treatment.

PURPOSE: This clinical trial is studying how well PET scans and CT scans show response to treatment in patients with locally advanced head and neck cancer undergoing chemotherapy and radiation therapy.

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Key information

About this study

OBJECTIVES:

Primary

  • Determine the feasibility of performing positron emission tomography-computed tomography (PET-CT) imaging for early discrimination of treatment response and post-therapy neck management in patients with locally advanced cancer of the head and neck treated with definitive chemoradiotherapy.

Secondary

  • Perform semiquantitative analysis of tracer uptake in these patients using standard uptake values and qualitative analysis of tracer uptake using pure visual analysis.
  • Determine the feasibility of distinguishing benign from malignant processes during initial tumor staging of these patients by whole-body PET-CT imaging.
  • Correlate staging by whole-body PET-CT imaging with staging by standard CT/MRI, clinical exam, and pathologic specimen.
  • Determine the feasibility of PET-CT imaging in these patients in treatment position for radiotherapy treatment planning, correlate the results with standard CT/MRI images, and record the differences.
  • Perform PET-CT imaging in these patients during weeks 2 and 4 of chemoradiotherapy to evaluate the predictive value of response to treatment at these time points.
  • Determine if the time interval for treatment monitoring at 6 and 12 weeks post chemoradiotherapy is important for the predictive value of PET-CT imaging.
  • Evaluate patients with clinical or radiographic abnormalities worrisome for residual or recurrent disease with PET-CT imaging at 6 and 12 weeks post chemoradiotherapy to assess the need for additional therapies (i.e., neck dissection).

OUTLINE: This is a pilot study.

Patients receive fludeoxyglucose F 18 (FDG) IV over 90 seconds prior to the initial scan. Patients undergo whole-body computed tomography (CT) imaging with contrast followed by positron emission tomography (PET) imaging (approximately 1 hour after FDG injection) for initial staging and simulation for radiotherapy treatment planning. After PET-CT evaluation, patients with locoregional disease are recommended for standard-care chemoradiotherapy. Patients with evidence of M1 disease that is confirmed by CT/MRI and/or biopsy are treated at the discretion of the attending clinician. During chemoradiotherapy, patients undergo PET-CT imaging, as described above, at the beginning of week 2 and during week 4 for treatment monitoring and early detection of recurrent or residual disease. Follow-up PET-CT scans are performed, as described previously, at 6 weeks and then at 3 months after completion of chemoradiotherapy.

After completion of study procedures, patients are followed periodically for up to 5 years.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed squamous cell carcinoma or lymphoepithelioma of the head and neck, including any of the following sites:
  • Oral cavity
  • Oropharynx
  • Hypopharynx
  • Larynx
  • Nasopharynx
  • Unknown primary of the head and neck region
  • Stage III or IV disease
  • Definitive chemoradiotherapy with curative intent must be planned

PATIENT CHARACTERISTICS:

  • Able to tolerate positron emission tomography (PET) imaging
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No poorly controlled diabetes mellitus (e.g., fasting glucose > 200 mg/dL) despite medication

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior radiotherapy to head and neck

Treatment and study plan

Primary outcomes

  1. Prognostic value of positron emission tomography-computed tomography imaging in predicting clinical response at baseline, at weeks 2 and 4, and at week 6 post chemoradiotherapy

    Time frame: 3 months

    The results of the experimental scans will be compared to the response to radiation therapy as measured by routine scans at 6 weeks and 3 months after completion of therapy

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

A Pilot Feasibility Study of PET-CT Imaging in Patients With Cancer of the Head and Neck Treated With Definitive Chemoradiation

Important dates

Study start
2006
Primary completion
2008
Study completion
2015
First posted
Oct 13, 2006
Registry last updated
May 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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