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

NCT ID: NCT00388024

Last Updated: 2017-05-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 19 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2015-01-31

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.

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.

Conditions

Carcinoma of Unknown Primary; Head and Neck Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kathryn M. Greven, MD

Role: STUDY_CHAIR

Wake Forest University Health Sciences

Locations

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

CCCWFU-60A05

Identifier Type: -

Identifier Source: secondary_id

CCCWFU-BG06-007

Identifier Type: -

Identifier Source: secondary_id

CDR0000504047

Identifier Type: -

Identifier Source: org_study_id