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


N/A
18 Years
N/A
Open (Enrolling)
Both
Carcinoma of Unknown Primary, Head and Neck Cancer

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Trial Information

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


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.

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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

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

Outcome Description:

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

Outcome Time Frame:

3 months

Safety Issue:

No

Principal Investigator

Kathryn M. Greven, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University

Authority:

United States: Institutional Review Board

Study ID:

CDR0000504047

NCT ID:

NCT00388024

Start Date:

February 2006

Completion Date:

Related Keywords:

  • Carcinoma of Unknown Primary
  • Head and Neck Cancer
  • stage III squamous cell carcinoma of the hypopharynx
  • 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 nasopharynx
  • stage III squamous cell carcinoma of the oropharynx
  • stage III lymphoepithelioma of the nasopharynx
  • stage III lymphoepithelioma of the oropharynx
  • squamous cell carcinoma of unknown primary
  • newly diagnosed carcinoma of unknown primary
  • metastatic squamous neck cancer with occult primary squamous cell carcinoma
  • untreated metastatic squamous neck cancer with occult primary
  • stage IV squamous cell carcinoma of the hypopharynx
  • 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 nasopharynx
  • stage IV squamous cell carcinoma of the oropharynx
  • stage IV lymphoepithelioma of the nasopharynx
  • stage IV lymphoepithelioma of the oropharynx
  • Carcinoma
  • Head and Neck Neoplasms
  • Neoplasms, Unknown Primary

Name

Location

Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096