To Evaluate the Impact of PET/CT on Radiation Treatment Planning in Relation to Changes in GTV in Stage 3 NSCLC
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|ClinicalTrials.gov Identifier: NCT01888692|
Recruitment Status : Terminated (Poor accural)
First Posted : June 28, 2013
Last Update Posted : June 28, 2013
|Condition or disease|
Primary objectives of the study:
1.To determine the impact of PET/CT fusion on gross tumor volume ( GTV ) for primary(GTVP) and nodal (GTVN) disease for each patient by comparing GTV contours using two separate data sets.
(A) GTVP CT+ ve and GTVN CT+ ve
(B) GTVP PET+ve and GTVN PET +ve
GTV will be measured and recorded in cubic centimeters for each volume.
1.Normal tissue toxicity:3D conformal Computerized radiation plans will be generated for the data sets GTVP and GTVN A and B .Dose Volume Histogram (DVH) will be determined and compared for the following normal tissue toxicity parameters.
I. V 20 Both lungs (Combined total lung volumes including PTV): Volume of both lungs receiving ≥ 20 G y, including planning target volume.
II. Mean lung dose: Mean radiation dose received by both lungs in a given radiation plan, calculated by the planning computer.
III. V 55 Esophagus: Volume of esophagus receiving≥ 55Gy.
IV. Mean esophageal dose : Mean radiation dose received by whole esophagus in a given radiation plan, calculated by the planning computer
V. Spinal cord dose: Maximum dose received by the spinal cord in a given radiation plan.
V1.. V40 Whole heart: Volume of heart receiving ≥ 40Gy
2A Inter observer variation: This will be determined for the data sets GTV A and B only delineated by 4 radiation oncologists blinded to each other, for first 20 patients. The resident involved in this project will be responsible to co-ordinate this part of the project. GTV will be measured and recorded in cubic centimeters for each volume.
2B Intra observer variation: This will be determined for the data sets GTV A and B only delineated by the same radiation oncologist (treating physician) at two different occasions, for first 20 patients. Minimum time interval between the two contours will be one month .The resident involved in this project will be responsible to co-ordinate this part of the project. GTV will be measured and recorded in cubic centimeters for each volume.
|Study Type :||Observational|
|Actual Enrollment :||29 participants|
|Official Title:||A Prospective Observational Study to Evaluate the Impact of PET/CT Simulation on Radiation Treatment Planning in Relation to Changes in GTV in Locally Advanced Non-small Cell Lung Cancer|
|Study Start Date :||April 2007|
|Actual Primary Completion Date :||August 2009|
|Actual Study Completion Date :||December 2010|
- Impact of PET/CT fusion on gross tumor volume for primary and nodal disease for each patient by comparing GTV contours using three separate data sets. [ Time Frame: From April 2007 -upto two years ]
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 ClinicalTrials.gov identifier (NCT number): NCT01888692
|Cancer Care Manitoba|
|Winnipeg, Manitoba, Canada, R3E0V9|
|Study Director:||Naseer Ahmed, MD||CancerCare Manitoba|