Trial Outcomes & Findings for Stereotactic Radiosurgery in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer (NCT NCT00852644)
NCT ID: NCT00852644
Last Updated: 2018-05-11
Results Overview
Number of Participants Who Did Not Experience a Dose Limiting Toxicity in the less than 3 centimeter cohort
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
9 participants
Primary outcome timeframe
6 weeks
Results posted on
2018-05-11
Participant Flow
9 patients were enrolled onto this study between January 2009 and August 2012 in the Radiation Oncology Clinic at Boston Medical Center
Participant milestones
| Measure |
56 Gray (LESS Than 3 Centimeter Cohort)
Intervention:
Procedure/Surgery: computed tomography Standard CT scans
Intervention:
Radiation: fludeoxyglucose F 18 standard doses with CT scans
Radiation: hypofractionated radiation therapy 4 doses over 2 weeks at 56 Gray
Radiation: stereotactic radiosurgery CyberKnife radiosurgery
|
62 Gray (LESS Than 3 Centimeter Cohort)
Intervention:
Procedure/Surgery: computed tomography Standard CT scans
Intervention:
Radiation: fludeoxyglucose F 18 standard doses with CT scans
Radiation: hypofractionated radiation therapy 4 doses over 2 weeks at 62 Gray
Radiation: stereotactic radiosurgery CyberKnife radiosurgery
|
68 Gray (LESS Than 3 Centimeter Cohort)
Intervention:
Procedure/Surgery: computed tomography Standard CT scans
Intervention:
Radiation: fludeoxyglucose F 18 standard doses with CT scans
Radiation: hypofractionated radiation therapy 4 doses over 2 weeks at 68 Gray
Radiation: stereotactic radiosurgery CyberKnife radiosurgery
|
56 Gray (MORE Than 3 Centimeter Cohort)
Intervention:
Procedure/Surgery: computed tomography Standard CT scans
Intervention:
Radiation: fludeoxyglucose F 18 standard doses with CT scans
Radiation: hypofractionated radiation therapy 4 doses over 2 weeks at 56 Gray
Radiation: stereotactic radiosurgery CyberKnife radiosurgery
|
62 Gray (MORE Than 3 Centimeter Cohort)
Intervention:
Procedure/Surgery: computed tomography Standard CT scans
Intervention:
Radiation: fludeoxyglucose F 18 standard doses with CT scans
Radiation: hypofractionated radiation therapy 4 doses over 2 weeks a 62 Gray
Radiation: stereotactic radiosurgery CyberKnife radiosurgery
|
68 Gray (MORE Than 3 Centimeter Cohort)
Intervention:
Procedure/Surgery: computed tomography Standard CT scans
Intervention:
Radiation: fludeoxyglucose F 18 standard doses with CT scans
Radiation: hypofractionated radiation therapy 4 doses over 2 weeks at 68 Gray
Radiation: stereotactic radiosurgery CyberKnife radiosurgery
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
0
|
3
|
0
|
0
|
|
Overall Study
COMPLETED
|
3
|
3
|
0
|
3
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Stereotactic Radiosurgery in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
CyberKnife
n=9 Participants
Intervention:
Procedure/Surgery: computed tomography Standard CT scans
Intervention:
Radiation: fludeoxyglucose F 18 standard doses with CT scans
Radiation: hypofractionated radiation therapy 4 doses over 2 weeks
Radiation: stereotactic radiosurgery CyberKnife radiosurgery
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 6 weeksNumber of Participants Who Did Not Experience a Dose Limiting Toxicity in the less than 3 centimeter cohort
Outcome measures
| Measure |
56 Gray (LESS Than 3 Centimeter Cohort)
n=3 Participants
Dose 1 (56 gray), less than 3 centimeter cohort
|
62 Gray (LESS Less Than 3 Centimeter Cohort)
n=3 Participants
Dose 2 (62 gray), less than 3 centimeter cohort
|
68 Gray (LESS Than 3 Centimeter Cohort)
Dose 3 (68 gray), less than 3 centimeter cohort
|
|---|---|---|---|
|
Participants Who Did Not Experience a Dose Limiting Toxicity in the Less Than 3 Centimeter Cohort
|
3 Participants
|
3 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: The highest tolerable dose between 56 gray, 62 gray and 68 gray has not been established as the protocol was terminated early.
The highest tolerable dose between 56 gray, 62 gray and 68 gray has not been established as the protocol was terminated early.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 6 weeksThe number of participants that did not experience a dose-limiting toxicity in the greater than 3 centimeter cohort
Outcome measures
| Measure |
56 Gray (LESS Than 3 Centimeter Cohort)
n=3 Participants
Dose 1 (56 gray), less than 3 centimeter cohort
|
62 Gray (LESS Less Than 3 Centimeter Cohort)
Dose 2 (62 gray), less than 3 centimeter cohort
|
68 Gray (LESS Than 3 Centimeter Cohort)
Dose 3 (68 gray), less than 3 centimeter cohort
|
|---|---|---|---|
|
Participants Who Did Not Experience a Dose Limiting Toxicity in the More Than 3 Centimeter Cohort
|
3 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: The highest tolerable dose between 56 gray, 62 gray and 68 gray has not been established as the protocol was terminated early.
The highest tolerable dose between 56 gray, 62 gray and 68 gray has not been established as the protocol was terminated early.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: before treatment and at 1, 3, 6, and 12 months after treatmentPopulation: Data were not collected and the outcome measure was not analyzed
Relationship between positron emission tomography (PET) response and local control and survival as measured by fludeoxyglucose F 18 PET/CT imaging
Outcome measures
Outcome data not reported
Adverse Events
56 Gray (LESS Than 3 Centimeter Cohort)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
62 Gray (LESS Than 3 Centimeter Cohort)
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
68 Gray (LESS Than 3 Centimeter Cohort)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
56 Gray (MORE Than 3 Centimeter Cohort)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
62 Gray (MORE Than 3 Centimeter Cohort)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
68 Gray (MORE Than 3 Centimeter Cohort)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
56 Gray (LESS Than 3 Centimeter Cohort)
n=3 participants at risk
Intervention:
Procedure/Surgery: computed tomography Standard CT scans
Intervention:
Radiation: fludeoxyglucose F 18 standard doses with CT scans
Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 56 Gray
Radiation: stereotactic radiosurgery CyberKnife radiosurgery
|
62 Gray (LESS Than 3 Centimeter Cohort)
n=3 participants at risk
Intervention:
Procedure/Surgery: computed tomography Standard CT scans
Intervention:
Radiation: fludeoxyglucose F 18 standard doses with CT scans
Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 62 Gray
Radiation: stereotactic radiosurgery CyberKnife radiosurgery
|
68 Gray (LESS Than 3 Centimeter Cohort)
Intervention:
Procedure/Surgery: computed tomography Standard CT scans
Intervention:
Radiation: fludeoxyglucose F 18 standard doses with CT scans
Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 68 Gray
Radiation: stereotactic radiosurgery CyberKnife radiosurgery
|
56 Gray (MORE Than 3 Centimeter Cohort)
n=3 participants at risk
Intervention:
Procedure/Surgery: computed tomography Standard CT scans
Intervention:
Radiation: fludeoxyglucose F 18 standard doses with CT scans
Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 56 Gray
Radiation: stereotactic radiosurgery CyberKnife radiosurgery
|
62 Gray (MORE Than 3 Centimeter Cohort)
Intervention:
Procedure/Surgery: computed tomography Standard CT scans
Intervention:
Radiation: fludeoxyglucose F 18 standard doses with CT scans
Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 62 Gray
Radiation: stereotactic radiosurgery CyberKnife radiosurgery
|
68 Gray (MORE Than 3 Centimeter Cohort)
Intervention:
Procedure/Surgery: computed tomography Standard CT scans
Intervention:
Radiation: fludeoxyglucose F 18 standard doses with CT scans
Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 68 Gray
Radiation: stereotactic radiosurgery CyberKnife radiosurgery
|
|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Forced Expiratory Volume in One Second (FEV1)
|
33.3%
1/3 • Number of events 1 • 6 months
|
0.00%
0/3 • 6 months
|
—
0/0 • 6 months
|
0.00%
0/3 • 6 months
|
—
0/0 • 6 months
|
—
0/0 • 6 months
|
|
Endocrine disorders
diabetes
|
0.00%
0/3 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
—
0/0 • 6 months
|
0.00%
0/3 • 6 months
|
—
0/0 • 6 months
|
—
0/0 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Diffusing capacity of the lungs for carbon monoxide (DLCO)
|
33.3%
1/3 • Number of events 1 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
—
0/0 • 6 months
|
0.00%
0/3 • 6 months
|
—
0/0 • 6 months
|
—
0/0 • 6 months
|
|
Musculoskeletal and connective tissue disorders
gait/walking
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
—
0/0 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
—
0/0 • 6 months
|
—
0/0 • 6 months
|
|
Investigations
hyperglycemia
|
0.00%
0/3 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
—
0/0 • 6 months
|
0.00%
0/3 • 6 months
|
—
0/0 • 6 months
|
—
0/0 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
hypoxia
|
33.3%
1/3 • Number of events 1 • 6 months
|
0.00%
0/3 • 6 months
|
—
0/0 • 6 months
|
0.00%
0/3 • 6 months
|
—
0/0 • 6 months
|
—
0/0 • 6 months
|
Other adverse events
| Measure |
56 Gray (LESS Than 3 Centimeter Cohort)
n=3 participants at risk
Intervention:
Procedure/Surgery: computed tomography Standard CT scans
Intervention:
Radiation: fludeoxyglucose F 18 standard doses with CT scans
Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 56 Gray
Radiation: stereotactic radiosurgery CyberKnife radiosurgery
|
62 Gray (LESS Than 3 Centimeter Cohort)
n=3 participants at risk
Intervention:
Procedure/Surgery: computed tomography Standard CT scans
Intervention:
Radiation: fludeoxyglucose F 18 standard doses with CT scans
Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 62 Gray
Radiation: stereotactic radiosurgery CyberKnife radiosurgery
|
68 Gray (LESS Than 3 Centimeter Cohort)
Intervention:
Procedure/Surgery: computed tomography Standard CT scans
Intervention:
Radiation: fludeoxyglucose F 18 standard doses with CT scans
Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 68 Gray
Radiation: stereotactic radiosurgery CyberKnife radiosurgery
|
56 Gray (MORE Than 3 Centimeter Cohort)
n=3 participants at risk
Intervention:
Procedure/Surgery: computed tomography Standard CT scans
Intervention:
Radiation: fludeoxyglucose F 18 standard doses with CT scans
Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 56 Gray
Radiation: stereotactic radiosurgery CyberKnife radiosurgery
|
62 Gray (MORE Than 3 Centimeter Cohort)
Intervention:
Procedure/Surgery: computed tomography Standard CT scans
Intervention:
Radiation: fludeoxyglucose F 18 standard doses with CT scans
Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 62 Gray
Radiation: stereotactic radiosurgery CyberKnife radiosurgery
|
68 Gray (MORE Than 3 Centimeter Cohort)
Intervention:
Procedure/Surgery: computed tomography Standard CT scans
Intervention:
Radiation: fludeoxyglucose F 18 standard doses with CT scans
Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 68 Gray
Radiation: stereotactic radiosurgery CyberKnife radiosurgery
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
dehydration
|
33.3%
1/3 • Number of events 1 • 6 months
|
0.00%
0/3 • 6 months
|
—
0/0 • 6 months
|
0.00%
0/3 • 6 months
|
—
0/0 • 6 months
|
—
0/0 • 6 months
|
|
Skin and subcutaneous tissue disorders
dry skin
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
—
0/0 • 6 months
|
33.3%
1/3 • Number of events 2 • 6 months
|
—
0/0 • 6 months
|
—
0/0 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
33.3%
1/3 • Number of events 1 • 6 months
|
0.00%
0/3 • 6 months
|
—
0/0 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
—
0/0 • 6 months
|
—
0/0 • 6 months
|
|
General disorders
fatigue
|
66.7%
2/3 • Number of events 2 • 6 months
|
66.7%
2/3 • Number of events 2 • 6 months
|
—
0/0 • 6 months
|
0.00%
0/3 • 6 months
|
—
0/0 • 6 months
|
—
0/0 • 6 months
|
|
Musculoskeletal and connective tissue disorders
gait/walking
|
0.00%
0/3 • 6 months
|
66.7%
2/3 • Number of events 2 • 6 months
|
—
0/0 • 6 months
|
0.00%
0/3 • 6 months
|
—
0/0 • 6 months
|
—
0/0 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
hypoxia
|
0.00%
0/3 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
—
0/0 • 6 months
|
0.00%
0/3 • 6 months
|
—
0/0 • 6 months
|
—
0/0 • 6 months
|
|
Musculoskeletal and connective tissue disorders
muscle weakness
|
0.00%
0/3 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
—
0/0 • 6 months
|
0.00%
0/3 • 6 months
|
—
0/0 • 6 months
|
—
0/0 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
pneumonitis
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
—
0/0 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
—
0/0 • 6 months
|
—
0/0 • 6 months
|
|
Cardiac disorders
myocardial infarction
|
33.3%
1/3 • Number of events 1 • 6 months
|
0.00%
0/3 • 6 months
|
—
0/0 • 6 months
|
0.00%
0/3 • 6 months
|
—
0/0 • 6 months
|
—
0/0 • 6 months
|
|
Gastrointestinal disorders
constipation
|
66.7%
2/3 • Number of events 2 • 6 months
|
0.00%
0/3 • 6 months
|
—
0/0 • 6 months
|
0.00%
0/3 • 6 months
|
—
0/0 • 6 months
|
—
0/0 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
33.3%
1/3 • Number of events 2 • 6 months
|
0.00%
0/3 • 6 months
|
—
0/0 • 6 months
|
0.00%
0/3 • 6 months
|
—
0/0 • 6 months
|
—
0/0 • 6 months
|
|
Skin and subcutaneous tissue disorders
erythema
|
33.3%
1/3 • Number of events 1 • 6 months
|
0.00%
0/3 • 6 months
|
—
0/0 • 6 months
|
0.00%
0/3 • 6 months
|
—
0/0 • 6 months
|
—
0/0 • 6 months
|
|
Nervous system disorders
dizziness
|
33.3%
1/3 • Number of events 1 • 6 months
|
0.00%
0/3 • 6 months
|
—
0/0 • 6 months
|
0.00%
0/3 • 6 months
|
—
0/0 • 6 months
|
—
0/0 • 6 months
|
|
Gastrointestinal disorders
dry mouth
|
33.3%
1/3 • Number of events 1 • 6 months
|
0.00%
0/3 • 6 months
|
—
0/0 • 6 months
|
0.00%
0/3 • 6 months
|
—
0/0 • 6 months
|
—
0/0 • 6 months
|
|
Musculoskeletal and connective tissue disorders
fibrosis-deep connective tissue
|
0.00%
0/3 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
—
0/0 • 6 months
|
0.00%
0/3 • 6 months
|
—
0/0 • 6 months
|
—
0/0 • 6 months
|
|
Gastrointestinal disorders
heartburn
|
66.7%
2/3 • Number of events 2 • 6 months
|
66.7%
2/3 • Number of events 2 • 6 months
|
—
0/0 • 6 months
|
0.00%
0/3 • 6 months
|
—
0/0 • 6 months
|
—
0/0 • 6 months
|
|
Skin and subcutaneous tissue disorders
hyperpigmentation
|
0.00%
0/3 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
—
0/0 • 6 months
|
0.00%
0/3 • 6 months
|
—
0/0 • 6 months
|
—
0/0 • 6 months
|
|
Infections and infestations
infection-other
|
0.00%
0/3 • 6 months
|
66.7%
2/3 • Number of events 3 • 6 months
|
—
0/0 • 6 months
|
0.00%
0/3 • 6 months
|
—
0/0 • 6 months
|
—
0/0 • 6 months
|
|
General disorders
insomnia
|
0.00%
0/3 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
—
0/0 • 6 months
|
0.00%
0/3 • 6 months
|
—
0/0 • 6 months
|
—
0/0 • 6 months
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal-other
|
0.00%
0/3 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
—
0/0 • 6 months
|
0.00%
0/3 • 6 months
|
—
0/0 • 6 months
|
—
0/0 • 6 months
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/3 • 6 months
|
33.3%
1/3 • Number of events 2 • 6 months
|
—
0/0 • 6 months
|
0.00%
0/3 • 6 months
|
—
0/0 • 6 months
|
—
0/0 • 6 months
|
|
General disorders
pain
|
0.00%
0/3 • 6 months
|
33.3%
1/3 • Number of events 2 • 6 months
|
—
0/0 • 6 months
|
0.00%
0/3 • 6 months
|
—
0/0 • 6 months
|
—
0/0 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
pleural effusion
|
33.3%
1/3 • Number of events 1 • 6 months
|
0.00%
0/3 • 6 months
|
—
0/0 • 6 months
|
0.00%
0/3 • 6 months
|
—
0/0 • 6 months
|
—
0/0 • 6 months
|
|
Reproductive system and breast disorders
pulmonary fibrosis
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
—
0/0 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
—
0/0 • 6 months
|
—
0/0 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary hypertension
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
—
0/0 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
—
0/0 • 6 months
|
—
0/0 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
voice changes
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
—
0/0 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
—
0/0 • 6 months
|
—
0/0 • 6 months
|
|
Gastrointestinal disorders
anorexia
|
33.3%
1/3 • Number of events 1 • 6 months
|
0.00%
0/3 • 6 months
|
—
0/0 • 6 months
|
0.00%
0/3 • 6 months
|
—
0/0 • 6 months
|
—
0/0 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place