Trial Outcomes & Findings for Image-Guided Adaptive Radiotherapy for in Detecting Tumors During Treatment in Patients With Head and Neck Cancer (NCT NCT01843673)

Last Updated: 2016-07-06

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

16 participants

Primary outcome timeframe

up to 7 weeks

Results posted on

2016-07-06

Participant Flow

Participant milestones

Participant milestones
Measure	Diagnostic (Imaging Technology) 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 Study STARTED	16
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Diagnostic (Imaging Technology) 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 Study Lack of Efficacy	2
Overall Study Withdrawal by Subject	4

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Diagnostic (Imaging Technology) n=16 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants
Age, Continuous	63 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 7 weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Orthogonal Varian kV OBI Image n=10 Participants 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.	Varian CBCT (Cone Beam CT) Imaging n=10 Participants 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.	Oblique Brainlab ExacTrac Images n=10 Participants 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.
Differences of Calculated Set up Errors of 2 mm Between the Different Imaging Technologies Vertical shift	-1.2 mm Standard Deviation 3.1	-0.8 mm Standard Deviation 3.4	-1.8 mm Standard Deviation 3.2
Differences of Calculated Set up Errors of 2 mm Between the Different Imaging Technologies Lateral shift	-1.5 mm Standard Deviation 3.3	-1.1 mm Standard Deviation 3.3	1.3 mm Standard Deviation 3.9

PRIMARY outcome

Timeframe: Up to 7 weeks

Population: No data analyzed due to staff leaving primary institution.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Up to 7 weeks

Population: No data analyzed due to staff leaving primary institution.

Outcome measures

Outcome data not reported

Adverse Events

Diagnostic (Imaging Technology)

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Diagnostic (Imaging Technology) n=16 participants at risk 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
Infections and infestations SEPSIS-ASSOCIATED ORGAN DYSFUNCTION	6.2% 1/16 • Number of events 1 • 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.

Other adverse events

Other adverse events
Measure	Diagnostic (Imaging Technology) n=16 participants at risk 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
Blood and lymphatic system disorders Below normal Glomerular filtration rate (GFR)	12.5% 2/16 • Number of events 2 • 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.
Blood and lymphatic system disorders Elevated Creatinine	37.5% 6/16 • Number of events 7 • 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.
Blood and lymphatic system disorders Elevated Blood Urea Nitrogen (BUN)	18.8% 3/16 • Number of events 3 • 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.

Additional Information

Joshua Evans, Ph.D.

Virginia Commonwealth University

Phone: 804-628-0661

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place