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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 : January 9, 2018
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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


Participant Flow:   Overall Study
    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)
STARTED   3   3   0   3   0   0 
COMPLETED   3   3   0   3   0   0 
NOT COMPLETED   0   0   0   0   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
CyberKnife

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


Baseline Measures
   CyberKnife 
Overall Participants Analyzed 
[Units: Participants]
 9 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      3  33.3% 
>=65 years      6  66.7% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      6  66.7% 
Male      3  33.3% 
Race (NIH/OMB) 
[Units: Participants]
Count of 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% 


  Outcome Measures

1.  Primary:   To Establish the Maximally Tolerated Dose of CyberKnife® Radiosurgery in the Less Than 3 Centimeter Cohort   [ Time Frame: 6 weeks ]

2.  Primary:   To Establish the Maximum Tolerated Dose in the Greater Than 3 Centimeter Cohort   [ Time Frame: 6 weeks ]

3.  Secondary:   Relationship Between Positron Emission Tomography (PET) Response and Local Control and Survival   [ Time Frame: before treatment and at 1, 3, 6, and 12 months after treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: minh-tam.truong@bmc.org



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: January 9, 2018