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Stereotactic Radiosurgery in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT00852644
Recruitment Status : Terminated (poor accrual)
First Posted : February 27, 2009
Results First Posted : January 9, 2018
Last Update Posted : May 11, 2018
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Minh Tam Truong, Boston Medical Center

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lung Cancer
Interventions Procedure: computed tomography
Radiation: fludeoxyglucose F 18
Radiation: hypofractionated radiation therapy
Radiation: stereotactic radiosurgery
Enrollment 9

Recruitment Details 9 patients were enrolled onto this study between January 2009 and August 2012 in the Radiation Oncology Clinic at Boston Medical Center
Pre-assignment Details  
Arm/Group Title 56 Gray (LESS Than 3 Centimeter Cohort) 62 Gray (LESS Than 3 Centimeter Cohort) 68 Gray (LESS Than 3 Centimeter Cohort) 56 Gray (MORE Than 3 Centimeter Cohort) 62 Gray (MORE Than 3 Centimeter Cohort) 68 Gray (MORE Than 3 Centimeter Cohort)
Hide Arm/Group Description

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

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

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

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

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

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

Period Title: Overall Study
Started 3 3 0 3 0 0
Completed 3 3 0 3 0 0
Not Completed 0 0 0 0 0 0
Arm/Group Title CyberKnife
Hide Arm/Group Description

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

Overall Number of Baseline Participants 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
<=18 years
0
   0.0%
Between 18 and 65 years
3
  33.3%
>=65 years
6
  66.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
Female
6
  66.7%
Male
3
  33.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
4
  44.4%
White
5
  55.6%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Participants Who Did Not Experience a Dose Limiting Toxicity in the Less Than 3 Centimeter Cohort
Hide Description Number of Participants Who Did Not Experience a Dose Limiting Toxicity in the less than 3 centimeter cohort
Time Frame 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 56 Gray (LESS Than 3 Centimeter Cohort) 62 Gray (LESS Less Than 3 Centimeter Cohort) 68 Gray (LESS Than 3 Centimeter Cohort)
Hide Arm/Group Description:
Dose 1 (56 gray), less than 3 centimeter cohort
Dose 2 (62 gray), less than 3 centimeter cohort
Dose 3 (68 gray), less than 3 centimeter cohort
Overall Number of Participants Analyzed 3 3 0
Measure Type: Count of Participants
Unit of Measure: Participants
3
 100.0%
3
 100.0%
0
2.Primary Outcome
Title Maximum Tolerated Dose in the Less Than 3 Centimeter Cohort
Hide Description The highest tolerable dose between 56 gray, 62 gray and 68 gray has not been established as the protocol was terminated early.
Time Frame 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The highest tolerable dose between 56 gray, 62 gray and 68 gray has not been established as the protocol was terminated early.
Arm/Group Title 56 Gray (LESS Than 3 Centimeter Cohort) 62 Gray (LESS Less Than 3 Centimeter Cohort) 68 Gray (LESS Than 3 Centimeter Cohort)
Hide Arm/Group Description:
Dose 1 (56 gray), less than 3 centimeter cohort
Dose 2 (62 gray), less than 3 centimeter cohort
Dose 3 (68 gray), less than 3 centimeter cohort
Overall Number of Participants Analyzed 0 0 0
Overall Number of Units Analyzed
Type of Units Analyzed: Dose
0 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Primary Outcome
Title Participants Who Did Not Experience a Dose Limiting Toxicity in the More Than 3 Centimeter Cohort
Hide Description The number of participants that did not experience a dose-limiting toxicity in the greater than 3 centimeter cohort
Time Frame 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 56 Gray (MORE Than 3 Centimeter Cohort) 62 Gray (MORE Than 3 Centimeter Cohort) 68 Gray (MORE Than 3 Centimeter Cohort)
Hide Arm/Group Description:

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

computed tomography: Standard CT scans

fludeoxyglucose F 18: standard doses with CT scans

hypofractionated radiation therapy: 4 doses over 2 weeks

stereotactic radiosurgery: CyberKnife radiosurgery

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

computed tomography: Standard CT scans

fludeoxyglucose F 18: standard doses with CT scans

hypofractionated radiation therapy: 4 doses over 2 weeks

stereotactic radiosurgery: CyberKnife radiosurgery

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

computed tomography: Standard CT scans

fludeoxyglucose F 18: standard doses with CT scans

hypofractionated radiation therapy: 4 doses over 2 weeks

stereotactic radiosurgery: CyberKnife radiosurgery

Overall Number of Participants Analyzed 3 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
3
 100.0%
0 0
4.Primary Outcome
Title Maximum Tolerated Dose - More Than 3 Centimeter Cohort.
Hide Description The highest tolerable dose between 56 gray, 62 gray and 68 gray has not been established as the protocol was terminated early.
Time Frame 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The highest tolerable dose between 56 gray, 62 gray and 68 gray has not been established as the protocol was terminated early.
Arm/Group Title 56 Gray (MORE Than 3 Centimeter Cohort) 62 Gray (MORE Than 3 Centimeter Cohort) 68 Gray (MORE Than 3 Centimeter Cohort)
Hide Arm/Group Description:

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

computed tomography: Standard CT scans

fludeoxyglucose F 18: standard doses with CT scans

hypofractionated radiation therapy: 4 doses over 2 weeks

stereotactic radiosurgery: CyberKnife radiosurgery

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

computed tomography: Standard CT scans

fludeoxyglucose F 18: standard doses with CT scans

hypofractionated radiation therapy: 4 doses over 2 weeks

stereotactic radiosurgery: CyberKnife radiosurgery

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

computed tomography: Standard CT scans

fludeoxyglucose F 18: standard doses with CT scans

hypofractionated radiation therapy: 4 doses over 2 weeks

stereotactic radiosurgery: CyberKnife radiosurgery

Overall Number of Participants Analyzed 0 0 0
Overall Number of Units Analyzed
Type of Units Analyzed: Dose
0 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Relationship Between Positron Emission Tomography (PET) Response and Local Control and Survival
Hide Description Relationship between positron emission tomography (PET) response and local control and survival as measured by fludeoxyglucose F 18 PET/CT imaging
Time Frame before treatment and at 1, 3, 6, and 12 months after treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data were not collected and the outcome measure was not analyzed
Arm/Group Title CyberKnife
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 56 Gray (LESS Than 3 Centimeter Cohort) 62 Gray (LESS Than 3 Centimeter Cohort) 68 Gray (LESS Than 3 Centimeter Cohort) 56 Gray (MORE Than 3 Centimeter Cohort) 62 Gray (MORE Than 3 Centimeter Cohort) 68 Gray (MORE Than 3 Centimeter Cohort)
Hide Arm/Group Description

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

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

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

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

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

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

All-Cause Mortality
56 Gray (LESS Than 3 Centimeter Cohort) 62 Gray (LESS Than 3 Centimeter Cohort) 68 Gray (LESS Than 3 Centimeter Cohort) 56 Gray (MORE Than 3 Centimeter Cohort) 62 Gray (MORE Than 3 Centimeter Cohort) 68 Gray (MORE Than 3 Centimeter Cohort)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)      0/3 (0.00%)      0/0      0/3 (0.00%)      0/0      0/0    
Show Serious Adverse Events Hide Serious Adverse Events
56 Gray (LESS Than 3 Centimeter Cohort) 62 Gray (LESS Than 3 Centimeter Cohort) 68 Gray (LESS Than 3 Centimeter Cohort) 56 Gray (MORE Than 3 Centimeter Cohort) 62 Gray (MORE Than 3 Centimeter Cohort) 68 Gray (MORE Than 3 Centimeter Cohort)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/3 (33.33%)      2/3 (66.67%)      0/0      1/3 (33.33%)      0/0      0/0    
Endocrine disorders             
diabetes  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/0  0 0/3 (0.00%)  0 0/0  0 0/0  0
Investigations             
hyperglycemia  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/0  0 0/3 (0.00%)  0 0/0  0 0/0  0
Musculoskeletal and connective tissue disorders             
gait/walking  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0 1/3 (33.33%)  1 0/0  0 0/0  0
Respiratory, thoracic and mediastinal disorders             
Forced Expiratory Volume in One Second (FEV1)  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/0  0 0/3 (0.00%)  0 0/0  0 0/0  0
Diffusing capacity of the lungs for carbon monoxide (DLCO)  1  1/3 (33.33%)  1 1/3 (33.33%)  1 0/0  0 0/3 (0.00%)  0 0/0  0 0/0  0
hypoxia  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/0  0 0/3 (0.00%)  0 0/0  0 0/0  0
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
56 Gray (LESS Than 3 Centimeter Cohort) 62 Gray (LESS Than 3 Centimeter Cohort) 68 Gray (LESS Than 3 Centimeter Cohort) 56 Gray (MORE Than 3 Centimeter Cohort) 62 Gray (MORE Than 3 Centimeter Cohort) 68 Gray (MORE Than 3 Centimeter Cohort)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/3 (100.00%)      3/3 (100.00%)      0/0      3/3 (100.00%)      0/0      0/0    
Cardiac disorders             
myocardial infarction  1 [1]  1/3 (33.33%)  1 0/3 (0.00%)  0 0/0  0 0/3 (0.00%)  0 0/0  0 0/0  0
Gastrointestinal disorders             
dehydration  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/0  0 0/3 (0.00%)  0 0/0  0 0/0  0
constipation  1  2/3 (66.67%)  2 0/3 (0.00%)  0 0/0  0 0/3 (0.00%)  0 0/0  0 0/0  0
dry mouth  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/0  0 0/3 (0.00%)  0 0/0  0 0/0  0
heartburn  1  2/3 (66.67%)  2 2/3 (66.67%)  2 0/0  0 0/3 (0.00%)  0 0/0  0 0/0  0
nausea  1  0/3 (0.00%)  0 1/3 (33.33%)  2 0/0  0 0/3 (0.00%)  0 0/0  0 0/0  0
anorexia  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/0  0 0/3 (0.00%)  0 0/0  0 0/0  0
General disorders             
fatigue  1  2/3 (66.67%)  2 2/3 (66.67%)  2 0/0  0 0/3 (0.00%)  0 0/0  0 0/0  0
insomnia  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/0  0 0/3 (0.00%)  0 0/0  0 0/0  0
pain  1  0/3 (0.00%)  0 1/3 (33.33%)  2 0/0  0 0/3 (0.00%)  0 0/0  0 0/0  0
Infections and infestations             
infection-other  1  0/3 (0.00%)  0 2/3 (66.67%)  3 0/0  0 0/3 (0.00%)  0 0/0  0 0/0  0
Musculoskeletal and connective tissue disorders             
gait/walking  1  0/3 (0.00%)  0 2/3 (66.67%)  2 0/0  0 0/3 (0.00%)  0 0/0  0 0/0  0
muscle weakness  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/0  0 0/3 (0.00%)  0 0/0  0 0/0  0
fibrosis-deep connective tissue  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/0  0 0/3 (0.00%)  0 0/0  0 0/0  0
musculoskeletal-other  1 [2]  0/3 (0.00%)  0 1/3 (33.33%)  1 0/0  0 0/3 (0.00%)  0 0/0  0 0/0  0
Nervous system disorders             
dizziness  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/0  0 0/3 (0.00%)  0 0/0  0 0/0  0
Reproductive system and breast disorders             
pulmonary fibrosis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0 1/3 (33.33%)  1 0/0  0 0/0  0
Respiratory, thoracic and mediastinal disorders             
dyspnea  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/0  0 1/3 (33.33%)  1 0/0  0 0/0  0
hypoxia  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/0  0 0/3 (0.00%)  0 0/0  0 0/0  0
pneumonitis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0 1/3 (33.33%)  1 0/0  0 0/0  0
cough  1  1/3 (33.33%)  2 0/3 (0.00%)  0 0/0  0 0/3 (0.00%)  0 0/0  0 0/0  0
pleural effusion  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/0  0 0/3 (0.00%)  0 0/0  0 0/0  0
pulmonary hypertension  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0 1/3 (33.33%)  1 0/0  0 0/0  0
voice changes  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0 1/3 (33.33%)  1 0/0  0 0/0  0
Skin and subcutaneous tissue disorders             
dry skin  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/0  0 1/3 (33.33%)  2 0/0  0 0/0  0
erythema  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/0  0 0/3 (0.00%)  0 0/0  0 0/0  0
hyperpigmentation  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/0  0 0/3 (0.00%)  0 0/0  0 0/0  0
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
[1]
Presented to Emergency Department with chest pain. Treated for non-ST segment elevation myocardial infarction) - Grade 1
[2]
left sided muscle soreness
The highest tolerable dose was not established in either cohort due to early termination. There were no dose limiting toxicities experienced at 56 or 62 gray (less than 3 centimeters) or 56 gray (more than 3 centimeters) at the time of study closure
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Minh Tam Truong
Organization: Boston Medical Center
Phone: 617-638-7070
Responsible Party: Minh Tam Truong, Boston Medical Center
ClinicalTrials.gov Identifier: NCT00852644     History of Changes
Other Study ID Numbers: H-26701
CDR0000635119 ( Other Grant/Funding Number: Department of Defense )
First Submitted: February 26, 2009
First Posted: February 27, 2009
Results First Submitted: February 13, 2017
Results First Posted: January 9, 2018
Last Update Posted: May 11, 2018