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Trial record 1 of 1 for:    z4099
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Surgery With or Without Internal Radiation Therapy Compared With Stereotactic Body Radiation Therapy in Treating Patients With High-Risk Stage I Non-Small Cell Lung Cancer

This study has been terminated.
(recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT01336894
First received: April 15, 2011
Last updated: February 8, 2017
Last verified: February 2017
Results First Received: November 28, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Lung Cancer
Interventions: Procedure: therapeutic conventional surgery
Radiation: iodine I 125
Radiation: stereotactic body radiation therapy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Thirteen (13) participants were accrued between August 2011 and January 2013. The study was terminated prematurely on May 15, 2013 due to lack of accrual. No further follow up data are expected as of that date.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Two participants on Arm I refused/withdrew prior to beginning of protocol interventions. These two participants were excluded from all analyses.

Reporting Groups
  Description
Arm I (SR+Brachytherapy) Patients undergo sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy with or without intraoperative brachytherapy comprising an iodine I 125 implant at the resection margin.
Arm II (SBRT) Patients undergo 3 fractions of stereotactic body radiation therapy (SBRT) at 2-8 days apart.

Participant Flow for 2 periods

Period 1:   Protocol Interventions
    Arm I (SR+Brachytherapy)   Arm II (SBRT)
STARTED   4   7 
COMPLETED   4   7 
NOT COMPLETED   0   0 

Period 2:   Follow-up
    Arm I (SR+Brachytherapy)   Arm II (SBRT)
STARTED   4   7 
COMPLETED   2   0 
NOT COMPLETED   2   7 
Study terminated prematurely                2                7 



  Baseline Characteristics
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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
Arm I (SR+Brachytherapy) Patients undergo sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy with or without intraoperative brachytherapy comprising an iodine I 125 implant at the resection margin.
Arm II (SBRT) Patients undergo 3 fractions of stereotactic body radiation therapy (SBRT) at 2-8 days apart.
Total Total of all reporting groups

Baseline Measures
   Arm I (SR+Brachytherapy)   Arm II (SBRT)   Total 
Overall Participants Analyzed 
[Units: Participants]
 4   7   11 
Age 
[Units: Years]
Median (Full Range)
 65 
 (50 to 72) 
 68 
 (53 to 81) 
 68 
 (50 to 81) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      1  25.0%      3  42.9%      4  36.4% 
Male      3  75.0%      4  57.1%      7  63.6% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      0   0.0%      0   0.0%      0   0.0% 
Not Hispanic or Latino      4 100.0%      7 100.0%      11 100.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      1  14.3%      1   9.1% 
White      4 100.0%      6  85.7%      10  90.9% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
Canada   0   2   2 
United States   4   5   9 
Eastern Cooperative Oncology Group (ECOG) Performance Status 
[Units: Participants]
Count of Participants
     
0=Asymptomatic and fully active      2  50.0%      3  42.9%      5  45.5% 
1=Symptomatic and fully ambulatory      2  50.0%      4  57.1%      6  54.5% 
Institutional intent to use brachytherapy 
[Units: Participants]
Count of Participants
     
Yes      1  25.0%      2  28.6%      3  27.3% 
No      3  75.0%      5  71.4%      8  72.7% 
Baseline diffusing capacity of the lung for carbon monoxide (DLCO) 
[Units: Percentage of predicted]
Median (Full Range)
 46 
 (33 to 80) 
 43 
 (28 to 92) 
 44 
 (28 to 92) 
Baseline Forced Expiratory Volume in 1 second (FEV1) 
[Units: Percentage of predicted]
Median (Full Range)
 42 
 (22 to 65) 
 92 
 (44 to 118) 
 54 
 (22 to 118) 


  Outcome Measures
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1.  Primary:   3-year Overall Survival (OS) Rate   [ Time Frame: Up to 3 years post-randomization ]

2.  Secondary:   Loco-regional Recurrence-free Survival   [ Time Frame: Up to 5 years post-randomization ]

3.  Secondary:   Adverse Event Profiles at 1 Month Post-therapy   [ Time Frame: 1 month post-therapy ]

4.  Secondary:   Adverse Event Profiles at 3 Months Post-therapy   [ Time Frame: 3 months post-therapy ]

5.  Secondary:   Adverse Event Profiles at 12 Months Post-therapy   [ Time Frame: 12 months post-therapy ]

6.  Secondary:   Disease-free Survival   [ Time Frame: Up to 5 years post-randomization ]

7.  Secondary:   Pulmonary Function Test Values   [ Time Frame: Up to 12 months post-therapy ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Hiran C. Fernando, MD
Organization: Boston Medical Center
phone: 617-638-5600
e-mail: hiran.fernando@bmc.org


Publications of Results:

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT01336894     History of Changes
Other Study ID Numbers: Z4099
U10CA076001 ( US NIH Grant/Contract Award Number )
NCI-2011-02667 ( Registry Identifier: NCI Clinical Trials Reporting Office )
CDR0000698986 ( Registry Identifier: Physician Data Query )
Study First Received: April 15, 2011
Results First Received: November 28, 2016
Last Updated: February 8, 2017