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

NCT00658281 | Completed

• 1 other identifier: 2007-0132
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Breast Cancer; On Board Imager Kilovoltage; Cone Beam Computed Tomography; Electronic Portal Imaging Device; Lymph Nodes; CBCT; OBI KV

Outcome Measures

Primary Outcomes (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)

  CBCT scanning and OBI R or CT-on-rial system, 5 evaluations per patient, during 5-week radiation treatment period

Study Arms (1)

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; Procedure: OBI KV Imaging

Interventions

CBCT Scan PROCEDURE

Cone Beam Computed Tomography (CBCT) scan performed once a week.

OBI KV System + CBCT Scanning

OBI KV Imaging PROCEDURE

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

OBI KV System + CBCT Scanning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with breast cancer.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Xiaochun Wang, PhD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2008
• First Posted: April 14, 2008
• Study Start: March 1, 2008
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: October 7, 2015

Record last verified: 2015-10

Locations

US (1)