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Setup Variation in the Supraclavicular Lymph Nodes Treatment in Breast Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00658281
Recruitment Status : Completed
First Posted : April 14, 2008
Last Update Posted : October 7, 2015
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The goal of this clinical research study is to use the On Board Imager kilovoltage (OBI KV) system and cone beam computed tomography (CBCT) scanning or CT-on-rail system to look at how well a routine device called an electronic portal imaging device (EPID) can set up a patient to receive radiation therapy on the lymph nodes in the neck.

Condition or disease Intervention/treatment
Breast Cancer Procedure: CBCT Scan Procedure: OBI KV Imaging

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Study Type : Observational
Actual Enrollment : 28 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Pilot Study of Setup Variation in the Supraclavicular Lymph Nodes Treatment in Breast Cancer Patients Using On-Board Imaging System With Linear Accelerator
Study Start Date : March 2008
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
OBI KV System + CBCT Scanning
Breast cancer patient radiation treatment set up using OBI KV system and CBCT scanning or CT-on-rail system to verify standard EPID for positioning.
Procedure: CBCT Scan
Cone Beam Computed Tomography (CBCT) scan performed once a week.

Procedure: OBI KV Imaging
On Board Imager kilovoltage (OBI KV) Imaging performed once a week.

Primary Outcome Measures :
  1. System Failure (defined as 2 or more disagreements between the EPID and either OBI systems or CT-on-rail from among the 5 evaluations for a particular patient) [ Time Frame: CBCT scanning and OBI R or CT-on-rial system, 5 evaluations per patient, during 5-week radiation treatment period ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with breast cancer.

Inclusion Criteria:

  1. Histologically confirmed carcinoma of the breast.
  2. American Joint Committee on Cancer (AJCC) Stage I-III, or locally recurrent breast cancer
  3. Planned for radiation treatment of the supraclavicular and axillary apex nodal beds using a SCV field
  4. Age greater than or equal to 18 years, since classic breast cancer is a disease of adults
  5. Able to understand the current trial and give informed consent

Exclusion Criteria:

  1. Has bilateral breast cancer requiring radiation to both breasts due to anatomic constraints on planning CT
  2. inflammatory carcinoma due to altered treatment schedule

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00658281

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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
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Principal Investigator: Xiaochun Wang, PhD M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00658281     History of Changes
Other Study ID Numbers: 2007-0132
First Posted: April 14, 2008    Key Record Dates
Last Update Posted: October 7, 2015
Last Verified: October 2015
Keywords provided by M.D. Anderson Cancer Center:
Breast Cancer
On Board Imager Kilovoltage
Cone Beam Computed Tomography
Electronic Portal Imaging Device
Lymph Nodes
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases