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Surgery With or Without Internal Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00107172
First received: April 5, 2005
Last updated: May 2, 2017
Last verified: May 2017
Results First Received: September 2, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Lung Cancer
Interventions: Procedure: surgery
Radiation: brachytherapy

  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
Two hundred twenty-four (224) participants were accrued between January 2006 and January 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One participant on SR arm was enrolled from a site with a regulatory violation and 1 participant on SR+BX arm had no surgery. These two participants were excluded from all analyses.

Reporting Groups
  Description
Arm A (SR) Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
Arm B (SR + BX) Patients undergo sublobar resection plus brachytherapy (SR + BX)

Participant Flow:   Overall Study
    Arm A (SR)   Arm B (SR + BX)
STARTED   114   108 
COMPLETED   109   103 
NOT COMPLETED   5   5 
Withdrawal by Subject                1                0 
Death                0                2 
Other Reason                4                3 



  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.
All intent-to-treat (ITT) participants.

Reporting Groups
  Description
Arm A (SR) Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
Arm B (SR + BX) Patients undergo sublobar resection plus brachytherapy (SR + BX)
Total Total of all reporting groups

Baseline Measures
   Arm A (SR)   Arm B (SR + BX)   Total 
Overall Participants Analyzed 
[Units: Participants]
 114   108   222 
Age 
[Units: Years]
Median (Full Range)
 70 
 (49 to 85) 
 72 
 (50 to 87) 
 71 
 (49 to 87) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      65  57.0%      59  54.6%      124  55.9% 
Male      49  43.0%      49  45.4%      98  44.1% 
Region of Enrollment 
[Units: Participants]
     
Canada   0   1   1 
United States   114   107   221 
Eastern Cooperative Oncology Group (ECOG)Performance Status 
[Units: Participants]
     
0 = Asymptomatic and fully active   20   25   45 
1= Symptomatic and fully ambulatory   66   60   126 
2= Symptomatic and ambulatory   28   23   51 
Clinical Nodule Size (cm) 
[Units: Participants]
     
<= 2 cm   73   67   140 
> 2 cm   41   41   82 
Tumor Stage [1] 
[Units: Participants]
     
T1=Tumor <=3cm   114   104   218 
T2=Tumor > 3cm   0   3   3 
T3=Tumor of any size   0   1   1 
[1]

Tumor staging was defined by tumor location and size. T1=surrounded by lung/visceral pleura, without bronchoscopic evidence of invasion more proximal than the lobar bronchus.

T2=tumor involves main bronchus, >=2cm distal to the carina; invades the visceral pleura; associated with atelectasis/obstructive pneumonitis that extends to the hilar region but does not involve the entire lung.

T3=tumor directly invades chest wall, diaphragm, mediastinal pleura, parietal pericardium; tumor in the main bronchus <2cm distal to the carina but without involvement of the carina;

Metastatis stage, M0 [1] 
[Units: Participants]
 114   108   222 
[1] Metastasis stage refers to which organs the cancer has spread. M0 = No distant metastasis
Nodal Stage, N0 [1] 
[Units: Participants]
 114   108   222 
[1] Nodal stage refers to regional lymph node involvement. N0=No regional lymph node metastasis.
Baseline diffusing capacity of the lung for carbon monoxide (DLCO) 
[Units: Percentage of predicted]
Median (Full Range)
 47 
 (18 to 97) 
 45 
 (8 to 137) 
 46 
 (8 to 137) 
Baseline Forced Expiratory Volume in 1 second (FEV1) 
[Units: Percentage of Predicted]
Median (Full Range)
 48 
 (22 to 117) 
 53 
 (25 to 110) 
 50 
 (22 to 117) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Time to Local Recurrence   [ Time Frame: Up to 3 years ]

2.  Secondary:   Overall Survival (OS)   [ Time Frame: Up to 5 years ]

3.  Secondary:   Number of Participants Reported Local Recurrence at 3 Years   [ Time Frame: 3 years ]

4.  Secondary:   Number of Participants Reported Regional Recurrence at 3 Years   [ Time Frame: 3 years ]

5.  Secondary:   Number of Participants Reported Distant Recurrence at 3 Years   [ Time Frame: 3 years ]

6.  Secondary:   Mortality Rates at 30- and 90-day After Sublobar Resection   [ Time Frame: 90 days ]

7.  Secondary:   Number of Participants Reported Grade 3+ Adverse Events Within 90 Days After Sublobar Resection   [ Time Frame: 90 days ]

8.  Secondary:   Number of Participants Reported Grade 3+ Respiratory Adverse Events Within 90 Days After Sublobar Resection   [ Time Frame: 90 days ]

9.  Secondary:   Global QOL as Measured Using SF36 at Baseline, Month 3, 12 and 24   [ Time Frame: 24 months ]

10.  Secondary:   Dyspnea as Measured Using SOBQ at Baseline, Months 3, Months 12 and 24   [ Time Frame: 24 months ]

11.  Secondary:   FEV1% Measured at Baseline and Month 3   [ Time Frame: 3 months ]

12.  Secondary:   DLCO% Measured at Baseline and Month 3   [ Time Frame: 3 months ]


  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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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:

Other Publications:

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00107172     History of Changes
Other Study ID Numbers: ACOSOG-Z4032
CDR0000422346 ( Registry Identifier: NCI Physician Data Query )
Study First Received: April 5, 2005
Results First Received: September 2, 2015
Last Updated: May 2, 2017