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Trial Outcomes & Findings for Use of Cone Beam Kilovoltage Imaging in Patients Receiving Radiation Therapy for Head and Neck Cancer (NCT NCT00358007)

NCT ID: NCT00358007

Last Updated: 2025-05-04

Results Overview

Determine the magnitude of the systematic error of patient positioning as determined by cone beam CT (CBCT) and the desired placement based on the treatment planning CT scan. Every day, prior to radiation treatment, a CBCT will be performed. The CBCT images will be compared to the radiation therapy planning CT image just taken.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

30 participants

Primary outcome timeframe

Daily prior to radiation

Results posted on

2025-05-04

Participant Flow

Participant milestones

Participant milestones
Measure
Cone Beam CT
Undergo a cone beam CT scan
Overall Study
STARTED
30
Overall Study
COMPLETED
28
Overall Study
NOT COMPLETED
2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Use of Cone Beam Kilovoltage Imaging in Patients Receiving Radiation Therapy for Head and Neck Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Cone Beam CT
n=30 Participants
Undergo a cone beam CT scan
Age, Continuous
58.19 years
STANDARD_DEVIATION 12.21 • n=5 Participants
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
21 Participants
n=5 Participants
Age, Categorical
>=65 years
9 Participants
n=5 Participants
Sex: Female, Male
Female
9 Participants
n=5 Participants
Sex: Female, Male
Male
21 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
1 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
4 Participants
n=5 Participants
Race (NIH/OMB)
White
25 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
28 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
2 Participants
n=5 Participants
Region of Enrollment
United States
30 participants
n=5 Participants

PRIMARY outcome

Timeframe: Daily prior to radiation

Determine the magnitude of the systematic error of patient positioning as determined by cone beam CT (CBCT) and the desired placement based on the treatment planning CT scan. Every day, prior to radiation treatment, a CBCT will be performed. The CBCT images will be compared to the radiation therapy planning CT image just taken.

Outcome measures

Outcome measures
Measure
Cone Beam CT
n=28 Participants
PTV Reduction: The margin around the area to be treated with radiation is decreased due the image guidance of the cone beam CT
Average Interfraction Shift of Patients Undergoing Radiotherapy
Medial-lateral dimension
1.4 millimeters
Standard Deviation 1.4
Average Interfraction Shift of Patients Undergoing Radiotherapy
Superoinferior dimension
1.7 millimeters
Standard Deviation 1.9
Average Interfraction Shift of Patients Undergoing Radiotherapy
Anteroposterior dimension
1.8 millimeters
Standard Deviation 2.1

PRIMARY outcome

Timeframe: Daily after each radiotherapy treatment

To determine the magnitude of random variance (random error) in radiotherapy treatment of head and neck neoplasms

Outcome measures

Outcome measures
Measure
Cone Beam CT
n=28 Participants
PTV Reduction: The margin around the area to be treated with radiation is decreased due the image guidance of the cone beam CT
Average Residual Error Motion of Patients Undergoing Radiotherapy
Medial-lateral dimension
0.7 millimeters
Standard Deviation 0.8
Average Residual Error Motion of Patients Undergoing Radiotherapy
Superoinferior dimension
0.9 millimeters
Standard Deviation 0.9
Average Residual Error Motion of Patients Undergoing Radiotherapy
Anteroposterior dimension
0.9 millimeters
Standard Deviation 0.9

Adverse Events

Cone Beam CT

Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Cone Beam CT
n=30 participants at risk
Undergo a cone beam CT scan
General disorders
Death
3.3%
1/30 • Number of events 1

Other adverse events

Other adverse events
Measure
Cone Beam CT
n=30 participants at risk
Undergo a cone beam CT scan
General disorders
Mucositis
6.7%
2/30 • Number of events 2
General disorders
Dehydration
13.3%
4/30 • Number of events 4
General disorders
Fever
3.3%
1/30 • Number of events 1
General disorders
Fatigue
3.3%
1/30 • Number of events 1

Additional Information

Pramila Rani Anne, MD

Thomas Jefferson University

Phone: 215-955-6702

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place