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

Sponsor

Wake Forest University Health Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT00388024

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

107

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma of Unknown Primary Head and Neck Cancer

Detailed Description

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.

Study Design

Study Type:

Observational

Actual Enrollment :

19 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Feb 1, 2006

Actual Primary Completion Date :

Dec 1, 2008

Actual Study Completion Date :

Jan 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
cancer patients about to be treated with radiation therapy Patienta with histologically confirmed squamous cell or lymphoepithelioma of oral cavity, oropharynx, hypopharynx, larynx, nasopharynx, or unknown primary of the head and neck about to be treated with radiation therapy

Outcome Measures

Primary Outcome Measures

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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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