Multiple Respiration-Correlated Cone Beam Computed Tomography (CT) Scans to Reduce Target Positioning Errors in Radiotherapy Treatment of Thoracic Cancer - Full Text View

Sponsored by:	Memorial Sloan-Kettering Cancer Center
Information provided by:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00722605

Purpose

The purpose of this study is to use cone-beam CT scans to more accurately position the tumor during radiation and to see whether this method is more effective than the standard method of using 2D images (portal images), which is a type of X-ray. Cone-beam CT is a type of CT scanner attached to the treatment accelerator that produces 3D images of the patient.

The ability to eliminate the tumor with radiation depends in part on the accuracy of delivering the radiation to the lung. The position of the tumor changes because of normal breathing. Therefore, we want to improve the accuracy of the way the radiation is delivered to the tumor. With cone-beam CT scans taken before and during your treatment, we will be able to determine the location of the tumor with 3D images, measure how much the tumor moves as you breathe, and then position you so that the tumor will get the best delivery of radiation.

Condition	Intervention	Phase
Esophageal Cancer Lung Cancer	Procedure: cone-beam CT	Phase I Phase II

MedlinePlus related topics: CT Scans Cancer Esophageal Cancer Esophagus Disorders Lung Cancer Nuclear Scans Radiation Therapy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Single Group Assignment, Efficacy Study
Official Title:	The Use of Multiple Respiration-Correlated Cone Beam CT Scans to Reduce Target Positioning Errors in Radiotherapy Treatment of Thoracic Cancer.

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

To enhance the accuracy of treatment delivery by using a cone-beam CT guided patient positioning procedure, relative to the standard portal image guided procedure. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine the reduction in the proportion of patients with large target positioning errors using the cone-beam CT guided procedure. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]
To gather data on organ motion and setup errors in the thorax and how they vary over the treatment course, in order to develop efficient clinical correction strategies. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	July 2008
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental cone-beam CT based	Procedure: cone-beam CT You will have the following CT scans along with the standard weekly portal images:Before treatment you will have a CT scan (a respiratory-correlated CT scan) at the time of the radiation planning, or simulation planning.During the first week of treatment - you will have 5 cone-beam CT scans at days 1 through 5 of your radiation treatment schedule. During the remaining weeks of treatment - you will have a cone-beam CT scan every week. Depending on the number of treatments that your study doctor has prescribed for you, the number of weekly scans can be between 3 and 7. For all scans, an external monitor will be used to record your breathing. If needed, you will be repositioned by adjusting the radiation machine's treatment couch position.

Arms

Assigned Interventions

1: Experimental

cone-beam CT based

Procedure: cone-beam CT

You will have the following CT scans along with the standard weekly portal images:Before treatment you will have a CT scan (a respiratory-correlated CT scan) at the time of the radiation planning, or simulation planning.During the first week of treatment - you will have 5 cone-beam CT scans at days 1 through 5 of your radiation treatment schedule.

During the remaining weeks of treatment - you will have a cone-beam CT scan every week. Depending on the number of treatments that your study doctor has prescribed for you, the number of weekly scans can be between 3 and 7.
For all scans, an external monitor will be used to record your breathing.
If needed, you will be repositioned by adjusting the radiation machine's treatment couch position.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients must have histologic proof of a thoracic malignancy, confirmed at MSKCC and suitable for radiation therapy, in order to be eligible for this study.
Patients must be older than 18 years of age
At least part of the tumor must be visible as observed in a diagnostic or planning CT. Patients must have Karnofsky Performance Status ≥ 70%

Exclusion Criteria:

Pregnant Women

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00722605

Contacts

Contact: Kenneth Rosenzweig, MD		rosenzwk@mskcc.org
Contact: Gikas Mageras, PhD		magerasg@mskcc.org.

Locations

United States, New York
Memorial Sloan Kettering Cancer Center	Recruiting
New York, New York, United States, 10065
Contact: Kenneth Rosenzweig, MD rosenzwk@mskcc.org
Contact: Gikas Mageras, PhD magerasg@mskcc.org
Principal Investigator: Kenneth Rosenzweig, MD

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

Investigators

Principal Investigator:

Kenneth Rosenzweig, MD

Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Memorial Sloan-Kettering Cancer Center ( Kenneth Rosenzweig, MD )
Study ID Numbers:	08-080
Study First Received:	July 23, 2008
Last Updated:	January 19, 2009
ClinicalTrials.gov Identifier:	NCT00722605 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:

lung
esophageal
cone beam ct scan

Study placed in the following topic categories:

Thoracic Neoplasms
Digestive System Neoplasms
Gastrointestinal Diseases
Esophageal Neoplasms
Esophageal Cancer
Digestive System Diseases
Respiratory Tract Diseases

Lung Neoplasms
Esophageal Disorder
Head and Neck Neoplasms
Lung Diseases
Gastrointestinal Neoplasms
Esophageal Diseases

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Digestive System Neoplasms
Gastrointestinal Diseases
Esophageal Neoplasms
Neoplasms
Digestive System Diseases

Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Head and Neck Neoplasms
Lung Diseases
Gastrointestinal Neoplasms
Esophageal Diseases

ClinicalTrials.gov processed this record on May 07, 2009