Trial Outcomes & Findings for Stereotactic Radiosurgery in Treating Patients With Locally Advanced or Recurrent Head and Neck Cancer (NCT NCT00851253)
NCT ID: NCT00851253
Last Updated: 2018-01-17
Results Overview
Median time to local failure based on regional or distant metastatic disease
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
12 participants
Primary outcome timeframe
1 year
Results posted on
2018-01-17
Participant Flow
Participants were recruited from within the investigators clinic practice between February 2009 and August 2013
One subject that was enrolled onto the Boost Arm was withdrawn prior to undergoing cyberknife therapy due to disease progression.
Participant milestones
| Measure |
Group 1 (CK SRS Boost Therapy)
Radiation: CyberKnife Stereotactic Radiosurgery boost (2 fractionated doses) beginning 4-8 weeks after completion of standard therapy.
stereotactic radiosurgery: Given in 2 fractionated doses or 5 fractionated doses
|
Group 2 (CK SRS Salvage Therapy)
Radiation : CyberKnife® stereotactic radiosurgery salvage therapy (5 fractions) 3 times weekly.
stereotactic radiosurgery: Given in 2 fractionated doses or 5 fractionated doses
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
10
|
|
Overall Study
COMPLETED
|
1
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Group 1 (CK SRS Boost Therapy)
Radiation: CyberKnife Stereotactic Radiosurgery boost (2 fractionated doses) beginning 4-8 weeks after completion of standard therapy.
stereotactic radiosurgery: Given in 2 fractionated doses or 5 fractionated doses
|
Group 2 (CK SRS Salvage Therapy)
Radiation : CyberKnife® stereotactic radiosurgery salvage therapy (5 fractions) 3 times weekly.
stereotactic radiosurgery: Given in 2 fractionated doses or 5 fractionated doses
|
|---|---|---|
|
Overall Study
Disease Progression
|
1
|
0
|
Baseline Characteristics
Stereotactic Radiosurgery in Treating Patients With Locally Advanced or Recurrent Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
Group 1 (CK SRS Boost Therapy)
n=2 Participants
Radiation: CyberKnife Stereotactic Radiosurgery boost (2 fractionated doses) beginning 4-8 weeks after completion of standard therapy.
stereotactic radiosurgery: Given in 2 fractionated doses or 5 fractionated doses
|
Group 2 (CK SRS Salvage Therapy)
n=10 Participants
Radiation : CyberKnife® stereotactic radiosurgery salvage therapy (5 fractions) 3 times weekly.
stereotactic radiosurgery: Given in 2 fractionated doses or 5 fractionated doses
|
Total
n=12 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
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 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
|
1 Participants
n=7 Participants
|
1 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
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 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
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Boost subjects were not evaluable.
Median time to local failure based on regional or distant metastatic disease
Outcome measures
| Measure |
Group 1 (CK SRS Boost Therapy)
Radiation: CyberKnife Stereotactic Radiosurgery boost (2 fractionated doses) beginning 4-8 weeks after completion of standard therapy.
stereotactic radiosurgery: Given in 2 fractionated doses or 5 fractionated doses
|
Group 2 (CK SRS Salvage Therapy)
n=10 Participants
Radiation : CyberKnife® stereotactic radiosurgery salvage therapy (5 fractions) 3 times weekly.
stereotactic radiosurgery: Given in 2 fractionated doses or 5 fractionated doses
|
|---|---|---|
|
Duration of Local Control
|
—
|
4.6 number of months to local failure
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: 1 yearPopulation: One subject in the Boost Arm was withdrawn prior to Cyberknife therapy due to disease progression and was therefore not analyzed.
Number of patients with serious adverse events possibly related, probably related or definitely related to the study treatment
Outcome measures
| Measure |
Group 1 (CK SRS Boost Therapy)
n=1 Participants
Radiation: CyberKnife Stereotactic Radiosurgery boost (2 fractionated doses) beginning 4-8 weeks after completion of standard therapy.
stereotactic radiosurgery: Given in 2 fractionated doses or 5 fractionated doses
|
Group 2 (CK SRS Salvage Therapy)
n=10 Participants
Radiation : CyberKnife® stereotactic radiosurgery salvage therapy (5 fractions) 3 times weekly.
stereotactic radiosurgery: Given in 2 fractionated doses or 5 fractionated doses
|
|---|---|---|
|
Rates of Adverse Events Associated With Treatment
|
1 Participants
|
0 Participants
|
Adverse Events
Group 1 (CK SRS Boost Therapy)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Group 2 (CK SRS Salvage Therapy)
Serious events: 9 serious events
Other events: 10 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Group 1 (CK SRS Boost Therapy)
n=1 participants at risk
Radiation: CyberKnife Stereotactic Radiosurgery boost (2 fractionated doses) beginning 4-8 weeks after completion of standard therapy.
stereotactic radiosurgery: Given in 2 fractionated doses or 5 fractionated doses
|
Group 2 (CK SRS Salvage Therapy)
n=10 participants at risk
Radiation : CyberKnife® stereotactic radiosurgery salvage therapy (5 fractions) 3 times weekly.
stereotactic radiosurgery: Given in 2 fractionated doses or 5 fractionated doses
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Trismus
|
100.0%
1/1 • Number of events 1 • 1 year
|
10.0%
1/10 • Number of events 1 • 1 year
|
|
General disorders
pain
|
100.0%
1/1 • Number of events 1 • 1 year
|
20.0%
2/10 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
dehydration
|
100.0%
1/1 • Number of events 1 • 1 year
|
10.0%
1/10 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
dysphagia
|
0.00%
0/1 • 1 year
|
20.0%
2/10 • Number of events 2 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
0.00%
0/1 • 1 year
|
10.0%
1/10 • Number of events 1 • 1 year
|
|
General disorders
ulceration
|
0.00%
0/1 • 1 year
|
10.0%
1/10 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
hemorrhage
|
0.00%
0/1 • 1 year
|
30.0%
3/10 • Number of events 3 • 1 year
|
|
Blood and lymphatic system disorders
neutropenia
|
0.00%
0/1 • 1 year
|
10.0%
1/10 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
hemoglobinemia
|
0.00%
0/1 • 1 year
|
10.0%
1/10 • Number of events 1 • 1 year
|
|
General disorders
fatigue
|
0.00%
0/1 • 1 year
|
10.0%
1/10 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
osteonecrosis
|
0.00%
0/1 • 1 year
|
10.0%
1/10 • Number of events 1 • 1 year
|
|
Ear and labyrinth disorders
osteomyelitis
|
0.00%
0/1 • 1 year
|
10.0%
1/10 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
Group 1 (CK SRS Boost Therapy)
n=1 participants at risk
Radiation: CyberKnife Stereotactic Radiosurgery boost (2 fractionated doses) beginning 4-8 weeks after completion of standard therapy.
stereotactic radiosurgery: Given in 2 fractionated doses or 5 fractionated doses
|
Group 2 (CK SRS Salvage Therapy)
n=10 participants at risk
Radiation : CyberKnife® stereotactic radiosurgery salvage therapy (5 fractions) 3 times weekly.
stereotactic radiosurgery: Given in 2 fractionated doses or 5 fractionated doses
|
|---|---|---|
|
General disorders
pain
|
0.00%
0/1 • 1 year
|
40.0%
4/10 • Number of events 4 • 1 year
|
|
Gastrointestinal disorders
anorexia
|
100.0%
1/1 • Number of events 1 • 1 year
|
0.00%
0/10 • 1 year
|
|
Gastrointestinal disorders
constipation
|
100.0%
1/1 • Number of events 1 • 1 year
|
20.0%
2/10 • Number of events 3 • 1 year
|
|
Gastrointestinal disorders
dysphagia
|
100.0%
1/1 • Number of events 1 • 1 year
|
10.0%
1/10 • Number of events 1 • 1 year
|
|
Psychiatric disorders
insomnia
|
100.0%
1/1 • Number of events 1 • 1 year
|
20.0%
2/10 • Number of events 2 • 1 year
|
|
General disorders
edema - head and neck
|
100.0%
1/1 • Number of events 1 • 1 year
|
30.0%
3/10 • Number of events 3 • 1 year
|
|
Nervous system disorders
dizziness
|
100.0%
1/1 • Number of events 1 • 1 year
|
10.0%
1/10 • Number of events 1 • 1 year
|
|
General disorders
fatigue
|
100.0%
1/1 • Number of events 1 • 1 year
|
20.0%
2/10 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
gait disturbance
|
100.0%
1/1 • Number of events 1 • 1 year
|
0.00%
0/10 • 1 year
|
|
Musculoskeletal and connective tissue disorders
muscle weakness
|
100.0%
1/1 • Number of events 1 • 1 year
|
0.00%
0/10 • 1 year
|
|
Blood and lymphatic system disorders
lypmphatics disorder - other
|
0.00%
0/1 • 1 year
|
10.0%
1/10 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/1 • 1 year
|
10.0%
1/10 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
taste alteration
|
0.00%
0/1 • 1 year
|
20.0%
2/10 • Number of events 2 • 1 year
|
|
Nervous system disorders
neurology - other
|
0.00%
0/1 • 1 year
|
10.0%
1/10 • Number of events 2 • 1 year
|
|
Skin and subcutaneous tissue disorders
dermatitis
|
0.00%
0/1 • 1 year
|
10.0%
1/10 • Number of events 1 • 1 year
|
|
Investigations
weight loss
|
0.00%
0/1 • 1 year
|
30.0%
3/10 • Number of events 3 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
voice alteration
|
0.00%
0/1 • 1 year
|
20.0%
2/10 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
mucositis
|
0.00%
0/1 • 1 year
|
20.0%
2/10 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
dry mouth
|
0.00%
0/1 • 1 year
|
20.0%
2/10 • Number of events 2 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
0.00%
0/1 • 1 year
|
10.0%
1/10 • Number of events 1 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place