Trial Outcomes & Findings for Stereotactic Body Radiotherapy for Head and Neck Tumors (NCT NCT01344356)
NCT ID: NCT01344356
Last Updated: 2020-04-10
Results Overview
Complete or partial tumor response or stable disease
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
19 participants
Primary outcome timeframe
5 years
Results posted on
2020-04-10
Participant Flow
Participant milestones
| Measure |
Benign Tumors
Benign head and neck tumors will be treated with stereotactic body radiation therapy
stereotactic body radiotherapy: 14-16 Gray / 1 fraction OR 18-21 Gray / 3 fractions (6-7 Gray per fraction)OR 25-45 Gray / 5 fractions (5-9 Gray per fraction)
|
Unrescectable Malignant Tumors
Malignant Head and Neck Tumors will be treated with stereotactic body radiation therapy.
Stereotactic body radiotherapy: 8-12 Gray / 1 fraction OR 12-18 Gray / 3 fractions (4-6 Gray per fraction) OR 35-45 Gray / 5 fractions (7-9 Gray per fraction)
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
18
|
|
Overall Study
COMPLETED
|
1
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
9
|
Reasons for withdrawal
| Measure |
Benign Tumors
Benign head and neck tumors will be treated with stereotactic body radiation therapy
stereotactic body radiotherapy: 14-16 Gray / 1 fraction OR 18-21 Gray / 3 fractions (6-7 Gray per fraction)OR 25-45 Gray / 5 fractions (5-9 Gray per fraction)
|
Unrescectable Malignant Tumors
Malignant Head and Neck Tumors will be treated with stereotactic body radiation therapy.
Stereotactic body radiotherapy: 8-12 Gray / 1 fraction OR 12-18 Gray / 3 fractions (4-6 Gray per fraction) OR 35-45 Gray / 5 fractions (7-9 Gray per fraction)
|
|---|---|---|
|
Overall Study
Physician Decision
|
0
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
6
|
Baseline Characteristics
Stereotactic Body Radiotherapy for Head and Neck Tumors
Baseline characteristics by cohort
| Measure |
Benign Tumors
n=1 Participants
Benign head and neck tumors will be treated with SBRT
stereotactic body radiotherapy: 14-16 Gy / 1 fraction OR 18-21 Gy / 3 fractions (6-7 Gy per fraction)OR 25-45 Gy / 5 fractions (5-9 Gy per fraction)
|
Unrescectable Malignant Tumors
n=18 Participants
Malignant Head and Neck Tumors will be treated with SBRT.
Stereotactic body radiotherapy: 8-12 Gy / 1 fraction OR 12-18 Gy / 3 fractions (4-6 Gy per fraction) OR 35-45 Gy / 5 fractions (7-9 Gy per fraction)
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: 12 patients did not have local control rate data reported. 3 patients were enrolled but never treated. 6 patients were lost to follow up. 3 patients died before data was collected.
Complete or partial tumor response or stable disease
Outcome measures
| Measure |
Benign Tumors
n=1 Participants
Benign head and neck tumors will be treated with SBRT
stereotactic body radiotherapy: 14-16 Gy / 1 fraction OR 18-21 Gy / 3 fractions (6-7 Gy per fraction)OR 25-45 Gy / 5 fractions (5-9 Gy per fraction)
|
Malignant Tumors
n=6 Participants
Malignant Head and Neck Tumors will be treated with SBRT.
Stereotactic body radiotherapy: 8-12 Gy / 1 fraction OR 12-18 Gy / 3 fractions (4-6 Gy per fraction) OR 35-45 Gy / 5 fractions (7-9 Gy per fraction)
|
|---|---|---|
|
Local Control Rate
|
1 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: 12 patients did not have local recurrence rate data reported. 3 patients were enrolled but never treated. 6 patients were lost to follow up. 3 patients died before data was collected.
Instances of progressive disease
Outcome measures
| Measure |
Benign Tumors
n=1 Participants
Benign head and neck tumors will be treated with SBRT
stereotactic body radiotherapy: 14-16 Gy / 1 fraction OR 18-21 Gy / 3 fractions (6-7 Gy per fraction)OR 25-45 Gy / 5 fractions (5-9 Gy per fraction)
|
Malignant Tumors
n=6 Participants
Malignant Head and Neck Tumors will be treated with SBRT.
Stereotactic body radiotherapy: 8-12 Gy / 1 fraction OR 12-18 Gy / 3 fractions (4-6 Gy per fraction) OR 35-45 Gy / 5 fractions (7-9 Gy per fraction)
|
|---|---|---|
|
Local Recurrence
|
0 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: 9 patients did not have local control rate data reported. 3 patients were enrolled but never treated. 6 patients were lost to follow up.
Number of participants with any adverse event
Outcome measures
| Measure |
Benign Tumors
n=1 Participants
Benign head and neck tumors will be treated with SBRT
stereotactic body radiotherapy: 14-16 Gy / 1 fraction OR 18-21 Gy / 3 fractions (6-7 Gy per fraction)OR 25-45 Gy / 5 fractions (5-9 Gy per fraction)
|
Malignant Tumors
n=9 Participants
Malignant Head and Neck Tumors will be treated with SBRT.
Stereotactic body radiotherapy: 8-12 Gy / 1 fraction OR 12-18 Gy / 3 fractions (4-6 Gy per fraction) OR 35-45 Gy / 5 fractions (7-9 Gy per fraction)
|
|---|---|---|
|
Complication Rate
|
1 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: 9 patients did not have overall survival data reported. 3 patients were enrolled but never treated. 6 patients were lost to follow up.
Number of participants who are alive 5 years following treatment.
Outcome measures
| Measure |
Benign Tumors
Benign head and neck tumors will be treated with SBRT
stereotactic body radiotherapy: 14-16 Gy / 1 fraction OR 18-21 Gy / 3 fractions (6-7 Gy per fraction)OR 25-45 Gy / 5 fractions (5-9 Gy per fraction)
|
Malignant Tumors
n=10 Participants
Malignant Head and Neck Tumors will be treated with SBRT.
Stereotactic body radiotherapy: 8-12 Gy / 1 fraction OR 12-18 Gy / 3 fractions (4-6 Gy per fraction) OR 35-45 Gy / 5 fractions (7-9 Gy per fraction)
|
|---|---|---|
|
Overall Survival
|
0 Participants
|
2 Participants
|
Adverse Events
Benign Tumors
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Malignant Tumors
Serious events: 0 serious events
Other events: 5 other events
Deaths: 8 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Benign Tumors
n=1 participants at risk
Benign head and neck tumors will be treated with SBRT
stereotactic body radiotherapy: 14-16 Gray / 1 fraction OR 18-21 Gray / 3 fractions (6-7 Gray per fraction)OR 25-45 Gray / 5 fractions (5-9 Gray per fraction)
|
Malignant Tumors
n=8 participants at risk
Malignant Head and Neck Tumors will be treated with SBRT.
Stereotactic body radiotherapy: 8-12 Gray / 1 fraction OR 12-18 Gray / 3 fractions (4-6 Gray per fraction) OR 35-45 Gray / 5 fractions (7-9 Gray per fraction)
|
|---|---|---|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/1 • 5 years
Only events that were considered possibly related to study treatment were recorded as adverse events. Events were graded and categorized using the CTCAE v3.0
|
25.0%
2/8 • 5 years
Only events that were considered possibly related to study treatment were recorded as adverse events. Events were graded and categorized using the CTCAE v3.0
|
|
Gastrointestinal disorders
Mucositis
|
100.0%
1/1 • 5 years
Only events that were considered possibly related to study treatment were recorded as adverse events. Events were graded and categorized using the CTCAE v3.0
|
12.5%
1/8 • 5 years
Only events that were considered possibly related to study treatment were recorded as adverse events. Events were graded and categorized using the CTCAE v3.0
|
|
General disorders
Hoarseness
|
0.00%
0/1 • 5 years
Only events that were considered possibly related to study treatment were recorded as adverse events. Events were graded and categorized using the CTCAE v3.0
|
25.0%
2/8 • 5 years
Only events that were considered possibly related to study treatment were recorded as adverse events. Events were graded and categorized using the CTCAE v3.0
|
|
General disorders
Fatigue
|
100.0%
1/1 • 5 years
Only events that were considered possibly related to study treatment were recorded as adverse events. Events were graded and categorized using the CTCAE v3.0
|
12.5%
1/8 • 5 years
Only events that were considered possibly related to study treatment were recorded as adverse events. Events were graded and categorized using the CTCAE v3.0
|
|
General disorders
Dizziness
|
100.0%
1/1 • 5 years
Only events that were considered possibly related to study treatment were recorded as adverse events. Events were graded and categorized using the CTCAE v3.0
|
0.00%
0/8 • 5 years
Only events that were considered possibly related to study treatment were recorded as adverse events. Events were graded and categorized using the CTCAE v3.0
|
|
Nervous system disorders
Cranial Nerve Neuropathy
|
100.0%
1/1 • 5 years
Only events that were considered possibly related to study treatment were recorded as adverse events. Events were graded and categorized using the CTCAE v3.0
|
0.00%
0/8 • 5 years
Only events that were considered possibly related to study treatment were recorded as adverse events. Events were graded and categorized using the CTCAE v3.0
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
100.0%
1/1 • 5 years
Only events that were considered possibly related to study treatment were recorded as adverse events. Events were graded and categorized using the CTCAE v3.0
|
0.00%
0/8 • 5 years
Only events that were considered possibly related to study treatment were recorded as adverse events. Events were graded and categorized using the CTCAE v3.0
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/1 • 5 years
Only events that were considered possibly related to study treatment were recorded as adverse events. Events were graded and categorized using the CTCAE v3.0
|
12.5%
1/8 • 5 years
Only events that were considered possibly related to study treatment were recorded as adverse events. Events were graded and categorized using the CTCAE v3.0
|
Additional Information
Mercy Research Manager - Regulatory Operations
Mercy Research
Phone: 314-251-8827
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place