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Image-Guided Adaptive Radiotherapy for in Detecting Tumors During Treatment in Patients With Head and Neck Cancer

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ClinicalTrials.gov Identifier: NCT01843673
Recruitment Status : Completed
First Posted : April 30, 2013
Results First Posted : March 21, 2016
Last Update Posted : July 6, 2016
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Head and Neck Cancer
Interventions Procedure: computed tomography
Procedure: cone-beam computed tomography
Procedure: radiography
Procedure: electronic portal imaging
Radiation: image-guided adaptive radiation therapy
Enrollment 16
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Diagnostic (Imaging Technology)
Hide Arm/Group Description

Patients undergo FBCT once before treatment and once weekly for a total of 6-7 scans, dual CBCT up to 5 times weekly for a total of 33-35 scans, 2-D x-ray with Varian kV OBI 5 times weekly for a total of 33-35 scans, 2-D x-ray with Brain Lab ExacTrac 5 times weekly for a total of 33-35 scans, 2-D x-ray with Varian MV OBI once weekly for a total of 6-7 scans, and EPID imaging up to 5 times weekly for a total of 33-35 scans while undergoing IGART.

computed tomography: Undergo FBCT cone-beam computed tomography: Undergo dual CBCT radiography: Undergo 2-D x-ray with Varian kV OBI radiography: Undergo 2-D x-ray with Brain Lab ExacTrac radiography: Undergo 2-D x-ray with Varian MV OBI electronic portal imaging: Undergo EPID imaging image-guided adaptive radiation therapy: Undergo IGART

Period Title: Overall Study
Started 16
Completed 10
Not Completed 6
Reason Not Completed
Lack of Efficacy             2
Withdrawal by Subject             4
Arm/Group Title Diagnostic (Imaging Technology)
Hide Arm/Group Description

Patients undergo FBCT once before treatment and once weekly for a total of 6-7 scans, dual CBCT up to 5 times weekly for a total of 33-35 scans, 2-D x-ray with Varian kV OBI 5 times weekly for a total of 33-35 scans, 2-D x-ray with Brain Lab ExacTrac 5 times weekly for a total of 33-35 scans, 2-D x-ray with Varian MV OBI once weekly for a total of 6-7 scans, and EPID imaging up to 5 times weekly for a total of 33-35 scans while undergoing IGART.

computed tomography: Undergo FBCT

cone-beam computed tomography: Undergo dual CBCT

radiography: Undergo 2-D x-ray with Varian kV OBI

radiography: Undergo 2-D x-ray with Brain Lab ExacTrac

radiography: Undergo 2-D x-ray with Varian MV OBI

electronic portal imaging: Undergo EPID imaging

image-guided adaptive radiation therapy: Undergo IGART

Overall Number of Baseline Participants 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
<=18 years
0
   0.0%
Between 18 and 65 years
9
  56.3%
>=65 years
7
  43.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants
63  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Female
0
   0.0%
Male
16
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
16
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
  12.5%
White
13
  81.3%
More than one race
0
   0.0%
Unknown or Not Reported
1
   6.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants
16
1.Primary Outcome
Title Differences of Calculated Set up Errors of 2 mm Between the Different Imaging Technologies
Hide Description The automated patient setup procedure varies between 'OBI', 'CBCT' or 'Exactrac' imaging technologies. Each procedure gives two shifts: 'vertical' and 'lateral'. In the absence of a gold standard, our goal is to compare the shifts recommended by each pair of automated patient setup procedures. Average and Std deviation of vertical and lateral motion from the three systems were computed. P value, 1.00, refers to the test of difference of each system with OBI being more than 2 mm. Pairwise comparison for each direction between each pair of technologies were done using a t test to check if the difference in the recommended shift is more than 2 mm. The reported mean value represents the shift from planned treatment position averaged over all daily treatment setups. A negative mean vertical value indicates the patient was consistently set up posterior to plan; a negative mean lateral value indicates a set up consistently right of plan.
Time Frame up to 7 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Ten evaluable head and neck patients treated with external beam radiation therapy received 19 to 32 fractions with all three imaging techniques. The mean daily shift of these 19 to 32 fractions were recorded for each technique. Statistical significance is determined based on 5% level of significance.
Arm/Group Title Orthogonal Varian kV OBI Image Varian CBCT (Cone Beam CT) Imaging Oblique Brainlab ExacTrac Images
Hide Arm/Group Description:
Patients are first set up for treatment with surface fiducial marks and followed by an automated image guided alignment procedure to achieve better alignment with the planning image. The automated procedure OBI gives two shifts: vertical and lateral. In the absence of a gold standard, our goal is to compare the vertical and lateral shifts recommended by each pair of automated procedures.
Patients are first set up for treatment with surface fiducial marks and followed by an automated image guided alignment procedure to achieve better alignment with the planning image. The automated procedure CBCT gives two shifts: vertical and lateral. In the absence of a gold standard, our goal is to compare the vertical and lateral shifts recommended by each pair of automated procedures.
Patients are first set up for treatment with surface fiducial marks and followed by an automated image guided alignment procedure to achieve better alignment with the planning image. The automated procedure ExacTrac gives two shifts: vertical and lateral. In the absence of a gold standard, our goal is to compare the vertical and lateral shifts recommended by each pair of automated procedures.
Overall Number of Participants Analyzed 10 10 10
Mean (Standard Deviation)
Unit of Measure: mm
Vertical shift -1.2  (3.1) -0.8  (3.4) -1.8  (3.2)
Lateral shift -1.5  (3.3) -1.1  (3.3) 1.3  (3.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Orthogonal Varian kV OBI Image, Varian CBCT (Cone Beam CT) Imaging
Comments Pairwise comparison for each direction between each pair of technologies were done using a t test to check if the difference in the recommended shift is more than 2 mm. Clinical significance is based on a 2 mm difference. Statistical significance is determined based on 5% level of significance.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Statistical significance testing at 5% level of significance, p-value being larger than 0.05 . The p-values for pairwise comparison.
Statistical Test of Hypothesis P-Value 1.00
Comments Statistical significance testing at 5% level of significance, p-value being larger than 0.05. The p-values for pairwise comparison lateral and vertical, for OBI and CBCT was 1.00.
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Orthogonal Varian kV OBI Image, Oblique Brainlab ExacTrac Images
Comments Pairwise comparison for each direction between each pair of technologies were done using a t test to check if the difference in the recommended shift is more than 2 mm. Clinical significance is based on a 2 mm difference. Statistical significance is determined based on 5% level of significance.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Statistical significance testing at 5% level of significance, p-value being larger than 0.05. Those are the p-values for pairwise comparison.
Statistical Test of Hypothesis P-Value 1.00
Comments Statistical significance testing at 5% level of significance, p-value being larger than 0.05. The p-values for pairwise comparison lateral and vertical, for OBI and ExacTrac was 1.00.
Method t-test, 2 sided
Comments [Not Specified]
2.Primary Outcome
Title Dose Variation Between the Different Imaging Technologies for Normal Tissue Structures of 10%
Hide Description [Not Specified]
Time Frame Up to 7 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
No data analyzed due to staff leaving primary institution.
Arm/Group Title Orthogonal Varian kV OBI Image Varian CBCT (Cone Beam CT) Imaging Oblique Brainlab ExacTrac Images
Hide Arm/Group Description:
Patients are first set up for treatment with surface fiducial marks and followed by an automated image guided alignment procedure to achieve better alignment with the planning image. The automated procedure OBI gives two shifts: vertical and lateral. In the absence of a gold standard, our goal is to compare the vertical and lateral shifts recommended by each pair of automated procedures.
Patients are first set up for treatment with surface fiducial marks and followed by an automated image guided alignment procedure to achieve better alignment with the planning image. The automated procedure CBCT gives two shifts: vertical and lateral. In the absence of a gold standard, our goal is to compare the vertical and lateral shifts recommended by each pair of automated procedures.
Patients are first set up for treatment with surface fiducial marks and followed by an automated image guided alignment procedure to achieve better alignment with the planning image. The automated procedure ExacTrac gives two shifts: vertical and lateral. In the absence of a gold standard, our goal is to compare the vertical and lateral shifts recommended by each pair of automated procedures.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Primary Outcome
Title Greater Than or Equal to 5% Variation of Normal Tissue Toxicity
Hide Description [Not Specified]
Time Frame Up to 7 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
No data analyzed due to staff leaving primary institution.
Arm/Group Title Orthogonal Varian kV OBI Image Varian CBCT (Cone Beam CT) Imaging Oblique Brainlab ExacTrac Images
Hide Arm/Group Description:
Patients are first set up for treatment with surface fiducial marks and followed by an automated image guided alignment procedure to achieve better alignment with the planning image. The automated procedure OBI gives two shifts: vertical and lateral. In the absence of a gold standard, our goal is to compare the vertical and lateral shifts recommended by each pair of automated procedures.
Patients are first set up for treatment with surface fiducial marks and followed by an automated image guided alignment procedure to achieve better alignment with the planning image. The automated procedure CBCT gives two shifts: vertical and lateral. In the absence of a gold standard, our goal is to compare the vertical and lateral shifts recommended by each pair of automated procedures.
Patients are first set up for treatment with surface fiducial marks and followed by an automated image guided alignment procedure to achieve better alignment with the planning image. The automated procedure ExacTrac gives two shifts: vertical and lateral. In the absence of a gold standard, our goal is to compare the vertical and lateral shifts recommended by each pair of automated procedures.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse Event Reporting were collected up to 7 weeks while the patient was undergoing the course of radiation therapy. No adverse events occurred due to additional xray imaging from this study.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Diagnostic (Imaging Technology)
Hide Arm/Group Description

Patients undergo FBCT once before treatment and once weekly for a total of 6-7 scans, dual CBCT up to 5 times weekly for a total of 33-35 scans, 2-D x-ray with Varian kV OBI 5 times weekly for a total of 33-35 scans, 2-D x-ray with Brain Lab ExacTrac 5 times weekly for a total of 33-35 scans, 2-D x-ray with Varian MV OBI once weekly for a total of 6-7 scans, and EPID imaging up to 5 times weekly for a total of 33-35 scans while undergoing IGART.

computed tomography: Undergo FBCT

cone-beam computed tomography: Undergo dual CBCT

radiography: Undergo 2-D x-ray with Varian kV OBI

radiography: Undergo 2-D x-ray with Brain Lab ExacTrac

radiography: Undergo 2-D x-ray with Varian MV OBI

electronic portal imaging: Undergo EPID imaging

image-guided adaptive radiation therapy: Undergo IGART

All-Cause Mortality
Diagnostic (Imaging Technology)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Diagnostic (Imaging Technology)
Affected / at Risk (%) # Events
Total   1/16 (6.25%)    
Infections and infestations   
SEPSIS-ASSOCIATED ORGAN DYSFUNCTION  1 [1]  1/16 (6.25%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (Unspecified)
[1]
Death not associated with CTCAE term - Sudden death. Cause of Death, SEPSIS-ASSOCIATED ORGAN DYSFUNCTION
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Diagnostic (Imaging Technology)
Affected / at Risk (%) # Events
Total   7/16 (43.75%)    
Blood and lymphatic system disorders   
Below normal Glomerular filtration rate (GFR)  1 [1]  2/16 (12.50%)  2
Elevated Creatinine  1 [2]  6/16 (37.50%)  7
Elevated Blood Urea Nitrogen (BUN) * 1 [3]  3/16 (18.75%)  3
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (Unspecified)
[1]
Metabolic/Laboratory, Glomerular filtration rate grade 1 and grade 2
[2]
3 events grade 1 and 4 events grade 2.
[3]
Metabolic/Laboratory - Other (Specify, __)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Joshua Evans, Ph.D.
Organization: Virginia Commonwealth University
Phone: 804-628-0661
Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01843673     History of Changes
Other Study ID Numbers: MCC-11639
NCI-2013-00846 ( Registry Identifier: NCI )
HM11639 ( Other Identifier: Virginia Commonwealth University IRB )
First Submitted: April 26, 2013
First Posted: April 30, 2013
Results First Submitted: December 18, 2015
Results First Posted: March 21, 2016
Last Update Posted: July 6, 2016