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A Pilot Study of Tumor and Critical Normal Tissue Motion in Head and Neck Cancer Using Cone Beam CT


N/A
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer

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Trial Information

A Pilot Study of Tumor and Critical Normal Tissue Motion in Head and Neck Cancer Using Cone Beam CT


Inclusion Criteria:



- Patients of all ages ≥18, both sexes, and all races will be included in this study.
Pregnant females will be excluded. No other special classes of subjects (i.e.,
prisoners) will be entered.

- Patients must be diagnosed with biopsy-proven squamous cell carcinoma of the head and
neck.

- Patients must be recommended treatment with definitive radiation therapy with
concurrent chemotherapy, but without prior surgical resection of the primary tumor or
lymph nodes

- Patients must be recommended a treatment course of at least 30 radiation fractions

- Patients must sign an informed consent form approved for this purpose by the
Institutional Review Board (IRB) of the University of Michigan Hospital indicating
that they are aware that undergoing cone beam CT of the head and neck is voluntary
and has potential risks.

Exclusion Criteria:

- Patients must not have a history of prior radiation to the head or neck

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Rate of Movement of Normal Tissue

Outcome Description:

The primary outcome measure of this study is to characterize patient-specific target and normal tissue movement.

Outcome Time Frame:

36 months

Safety Issue:

No

Principal Investigator

Avraham Eisbruch, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2005.084

NCT ID:

NCT01661062

Start Date:

January 2009

Completion Date:

January 2015

Related Keywords:

  • Head and Neck Cancer
  • Head and Neck Neoplasms

Name

Location

University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752