Trial Outcomes & Findings for A Study Using Cone Beam CT for Head and Neck Cancer (NCT NCT01661062)
NCT ID: NCT01661062
Last Updated: 2016-08-29
Results Overview
The primary outcome measure of this study is to characterize patient-specific target and normal tissue movement.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
23 participants
Primary outcome timeframe
approximately 7 weeks
Results posted on
2016-08-29
Participant Flow
Participant milestones
| Measure |
Cone Beam CT
For the purposes of this study patients will get CT scans every day for the length of their radiation therapy (in order to assess if CT every day provides additional information compared with CT scans performed less frequently).
Radiotherapy will be delivered according to current guidelines.
Imaging will be performed every day before treatment for a total of approximately 35 cone beam CT scans over the 7 week course of therapy.
|
|---|---|
|
Overall Study
STARTED
|
23
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Cone Beam CT
For the purposes of this study patients will get CT scans every day for the length of their radiation therapy (in order to assess if CT every day provides additional information compared with CT scans performed less frequently).
Radiotherapy will be delivered according to current guidelines.
Imaging will be performed every day before treatment for a total of approximately 35 cone beam CT scans over the 7 week course of therapy.
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|---|---|
|
Overall Study
Completed Treatment Off Study
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
A Study Using Cone Beam CT for Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
Cone Beam CT
n=18 Participants
For the purposes of this study patients will get CT scans every day for the length of their radiation therapy (in order to assess if CT every day provides additional information compared with CT scans performed less frequently).
Radiotherapy will be delivered according to current guidelines.
Imaging will be performed every day before treatment for a total of approximately 35 cone beam CT scans over the 7 week course of therapy.
|
|---|---|
|
Age, Continuous
|
57 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
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Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
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Disease Site
Base of Tongue
|
9 participants
n=5 Participants
|
|
Disease Site
Tonsil
|
9 participants
n=5 Participants
|
|
T Stage
T1
|
2 participants
n=5 Participants
|
|
T Stage
T2
|
10 participants
n=5 Participants
|
|
T Stage
T3
|
5 participants
n=5 Participants
|
|
T Stage
T4
|
1 participants
n=5 Participants
|
|
N Stage
N0
|
1 participants
n=5 Participants
|
|
N Stage
N1
|
0 participants
n=5 Participants
|
|
N Stage
N2a
|
1 participants
n=5 Participants
|
|
N Stage
N2b
|
10 participants
n=5 Participants
|
|
N Stage
N2c
|
4 participants
n=5 Participants
|
|
N Stage
N3
|
2 participants
n=5 Participants
|
|
Pre-Treatment Weight
|
203 lb
n=5 Participants
|
PRIMARY outcome
Timeframe: approximately 7 weeksThe primary outcome measure of this study is to characterize patient-specific target and normal tissue movement.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 24 monthsPopulation: 36 parotid glands were evaluable from 18 patients at baseline, 34 parotid glands were evaluable at 3-6 months, 32 glands were evaluable at 12 months, 20 were evaluable at 18 months and 8 at 24 months.
Spearman rank-based correlation coefficients were calculated for the association between saliva flow rate and the delivered mean parotid doses at several timepoints (Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months).
Outcome measures
| Measure |
Cone Beam CT
n=18 Participants
For the purposes of this study patients will get CT scans every day for the length of their radiation therapy (in order to assess if CT every day provides additional information compared with CT scans performed less frequently).
Radiotherapy will be delivered according to current guidelines.
Imaging will be performed every day before treatment for a total of approximately 35 cone beam CT scans over the 7 week course of therapy.
|
|---|---|
|
Correlation Coefficient for the Association Between Delivered Mean Parotid Dose and Salivary Flow Rate
3 Months
|
-0.42 correlation coefficient
|
|
Correlation Coefficient for the Association Between Delivered Mean Parotid Dose and Salivary Flow Rate
6 Months
|
-0.57 correlation coefficient
|
|
Correlation Coefficient for the Association Between Delivered Mean Parotid Dose and Salivary Flow Rate
Baseline
|
-0.26 correlation coefficient
|
|
Correlation Coefficient for the Association Between Delivered Mean Parotid Dose and Salivary Flow Rate
12 Months
|
-0.35 correlation coefficient
|
|
Correlation Coefficient for the Association Between Delivered Mean Parotid Dose and Salivary Flow Rate
18 Months
|
-0.42 correlation coefficient
|
|
Correlation Coefficient for the Association Between Delivered Mean Parotid Dose and Salivary Flow Rate
24 Months
|
-0.60 correlation coefficient
|
SECONDARY outcome
Timeframe: 36 monthsUse acquired data to further improve cone beam CT reconstruction techniques and image quality.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 7 weeksOutcome measures
| Measure |
Cone Beam CT
n=18 Participants
For the purposes of this study patients will get CT scans every day for the length of their radiation therapy (in order to assess if CT every day provides additional information compared with CT scans performed less frequently).
Radiotherapy will be delivered according to current guidelines.
Imaging will be performed every day before treatment for a total of approximately 35 cone beam CT scans over the 7 week course of therapy.
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|---|---|
|
The Median Delivered Dose of Radiation to the Parotid Gland
|
32.4 Gy
Interval 23.2 to 63.2
|
Adverse Events
Cone Beam CT
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cone Beam CT
n=18 participants at risk
For the purposes of this study patients will get CT scans every day for the length of their radiation therapy (in order to assess if CT every day provides additional information compared with CT scans performed less frequently).
Radiotherapy will be delivered according to current guidelines.
Imaging will be performed every day before treatment for a total of approximately 35 cone beam CT scans over the 7 week course of therapy.
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|---|---|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.6%
1/18 • Number of events 1
|
|
Renal and urinary disorders
Renal Failure
|
5.6%
1/18 • Number of events 1
|
Other adverse events
| Measure |
Cone Beam CT
n=18 participants at risk
For the purposes of this study patients will get CT scans every day for the length of their radiation therapy (in order to assess if CT every day provides additional information compared with CT scans performed less frequently).
Radiotherapy will be delivered according to current guidelines.
Imaging will be performed every day before treatment for a total of approximately 35 cone beam CT scans over the 7 week course of therapy.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Chemoradiation Rash
|
38.9%
7/18 • Number of events 12
|
|
Skin and subcutaneous tissue disorders
Radiation Rash
|
11.1%
2/18 • Number of events 4
|
|
Metabolism and nutrition disorders
Dehydration
|
44.4%
8/18 • Number of events 15
|
|
Gastrointestinal disorders
xerostomia
|
50.0%
9/18 • Number of events 30
|
|
Gastrointestinal disorders
Dysphagia
|
50.0%
9/18 • Number of events 21
|
|
Gastrointestinal disorders
Esophagitis
|
44.4%
8/18 • Number of events 17
|
|
Gastrointestinal disorders
Gastrointestinal Other
|
11.1%
2/18 • Number of events 7
|
|
Investigations
Mucositis/Stomatitis (upon exam)
|
50.0%
9/18 • Number of events 25
|
|
Gastrointestinal disorders
Mucositis/Stomatitis (symptomatic)
|
11.1%
2/18 • Number of events 3
|
|
Gastrointestinal disorders
Nausea
|
16.7%
3/18 • Number of events 6
|
|
Gastrointestinal disorders
Salivary Gland Changes
|
38.9%
7/18 • Number of events 22
|
|
Gastrointestinal disorders
Dysgeusia
|
50.0%
9/18 • Number of events 27
|
Additional Information
Avraham Eisbruch, M.D.
University of Michigan Comprehensive Cancer Center
Phone: 734-936-4302
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place