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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

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ClinicalTrials.gov Identifier: NCT01336894
Recruitment Status : Terminated (recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated)
First Posted : April 18, 2011
Results First Posted : March 28, 2017
Last Update Posted : May 30, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lung Cancer
Interventions Procedure: therapeutic conventional surgery
Radiation: iodine I 125
Radiation: stereotactic body radiation therapy
Enrollment 13
Recruitment Details 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 Two participants on Arm I refused/withdrew prior to beginning of protocol interventions. These two participants were excluded from all analyses.
Arm/Group Title Arm I (SR+Brachytherapy) Arm II (SBRT)
Hide Arm/Group Description 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. Patients undergo 3 fractions of stereotactic body radiation therapy (SBRT) at 2-8 days apart.
Period Title: Protocol Interventions
Started 4 7
Completed 4 7
Not Completed 0 0
Period Title: Follow-up
Started 4 7
Completed 2 0
Not Completed 2 7
Reason Not Completed
Study terminated prematurely             2             7
Arm/Group Title Arm I (SR+Brachytherapy) Arm II (SBRT) Total
Hide Arm/Group Description 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. Patients undergo 3 fractions of stereotactic body radiation therapy (SBRT) at 2-8 days apart. Total of all reporting groups
Overall Number of Baseline Participants 4 7 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 4 participants 7 participants 11 participants
65
(50 to 72)
68
(53 to 81)
68
(50 to 81)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 7 participants 11 participants
Female
1
  25.0%
3
  42.9%
4
  36.4%
Male
3
  75.0%
4
  57.1%
7
  63.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 7 participants 11 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)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 7 participants 11 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  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 4 participants 7 participants 11 participants
Canada 0 2 2
United States 4 5 9
Eastern Cooperative Oncology Group (ECOG) Performance Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 7 participants 11 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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 7 participants 11 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)  
Median (Full Range)
Unit of measure:  Percentage of predicted
Number Analyzed 4 participants 7 participants 11 participants
46
(33 to 80)
43
(28 to 92)
44
(28 to 92)
Baseline Forced Expiratory Volume in 1 second (FEV1)  
Median (Full Range)
Unit of measure:  Percentage of predicted
Number Analyzed 4 participants 7 participants 11 participants
42
(22 to 65)
92
(44 to 118)
54
(22 to 118)
1.Primary Outcome
Title 3-year Overall Survival (OS) Rate
Hide Description Overall survival is defined as the time from randomization until death from any cause.
Time Frame Up to 3 years post-randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated prematurely. Planned analyses was not performed due to the nature of the closure endpoint data is not available.
Arm/Group Title Arm I (SR+Brachytherapy) Arm II (SBRT)
Hide Arm/Group Description:
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.
Patients undergo 3 fractions of stereotactic body radiation therapy (SBRT) at 2-8 days apart.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Loco-regional Recurrence-free Survival
Hide Description Loco-regional recurrence is defined as recurrence within the same lobe or hilum (N1 nodes), or within 2 cm of the staple line or within 2 cm of the PTV after treatment effects such as scarring have subsided.
Time Frame Up to 5 years post-randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated prematurely. Planned analyses was not performed due to the nature of the closure endpoint data is not available.
Arm/Group Title Arm I (SR+Brachytherapy) Arm II (SBRT)
Hide Arm/Group Description:
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.
Patients undergo 3 fractions of stereotactic body radiation therapy (SBRT) at 2-8 days apart.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Adverse Event Profiles at 1 Month Post-therapy
Hide Description

Adverse events are described and graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 4.0.

Grading: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death.

Time Frame 1 month post-therapy
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received protocol interventions and had adverse events reported at 1 month post-therapy.
Arm/Group Title Arm I (SR+Brachytherapy) Arm II (SBRT)
Hide Arm/Group Description:
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.
Patients undergo 3 fractions of stereotactic body radiation therapy (SBRT) at 2-8 days apart.
Overall Number of Participants Analyzed 4 7
Measure Type: Count of Participants
Unit of Measure: Participants
Chest wall pain Grade 0 3 7
Grade 1 1 0
Grade 2 0 0
Cough Grade 0 3 5
Grade 1 1 2
Grade 2 0 0
Dyspnea Grade 0 4 6
Grade 1 0 1
Grade 2 0 0
Hoarness Grade 0 4 6
Grade 1 0 1
Grade 2 0 0
Hypoxia Grade 0 3 7
Grade 1 0 0
Grade 2 1 0
Fatigue Grade 0 4 6
Grade 1 0 0
Grade 2 0 1
4.Secondary Outcome
Title Adverse Event Profiles at 3 Months Post-therapy
Hide Description

Adverse events are described and graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 4.0.

Grading: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death.

Time Frame 3 months post-therapy
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received protocol interventions and had adverse event reported at months 3 post-therapy.
Arm/Group Title Arm I (SR+Brachytherapy) Arm II (SBRT)
Hide Arm/Group Description:
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.
Patients undergo 3 fractions of stereotactic body radiation therapy (SBRT) at 2-8 days apart.
Overall Number of Participants Analyzed 4 6
Measure Type: Count of Participants
Unit of Measure: Participants
Cough Grade 0 3 4
Grade 1 1 2
Grade 2 0 0
Hypoxia Grade 0 3 6
Grade 1 0 0
Grade 2 1 0
5.Secondary Outcome
Title Adverse Event Profiles at 12 Months Post-therapy
Hide Description

Adverse events are described and graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 4.0.

Grading: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death.

Time Frame 12 months post-therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated prematurely. Planned analyses was not performed due to the nature of the closure endpoint data is not available.
Arm/Group Title Arm I (SR+Brachytherapy) Arm II (SBRT)
Hide Arm/Group Description:
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.
Patients undergo 3 fractions of stereotactic body radiation therapy (SBRT) at 2-8 days apart.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Disease-free Survival
Hide Description Disease free survival is defined as the time from randomization until documented disease recurrence or death, whichever occurs first. Patient who are disease free and alive at the time of analysis will be censored at the time of their last follow up.
Time Frame Up to 5 years post-randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated prematurely. Planned analyses was not performed due to the nature of the closure endpoint data is not available.
Arm/Group Title Arm I (SR+Brachytherapy) Arm II (SBRT)
Hide Arm/Group Description:
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.
Patients undergo 3 fractions of stereotactic body radiation therapy (SBRT) at 2-8 days apart.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Pulmonary Function Test Values
Hide Description Pulmonary function test values include forced expiratory volume 1 (FEV1), carbon monoxide diffusion (DLCO) and forced vital capacity (FVC).
Time Frame Up to 12 months post-therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated prematurely. Planned analyses was not performed due to the nature of the closure endpoint data is not available.
Arm/Group Title Arm I (SR+Brachytherapy) Arm II (SBRT)
Hide Arm/Group Description:
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.
Patients undergo 3 fractions of stereotactic body radiation therapy (SBRT) at 2-8 days apart.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame All adverse events reported since the participants received the study interventions to the date the study was closed prematurely on May 15, 2013 with no further follow up expected; up to 2 years from the start of the study.
Adverse Event Reporting Description Adverse events are described and graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 4.0. Please note that the death NOS reported fell outside of the reporting window and was queried on but since the trial was terminated midstream the data management was not completed.
 
Arm/Group Title Arm I (SR+Brachytherapy) Arm II (SBRT)
Hide Arm/Group Description 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. Patients undergo 3 fractions of stereotactic body radiation therapy (SBRT) at 2-8 days apart.
All-Cause Mortality
Arm I (SR+Brachytherapy) Arm II (SBRT)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Arm I (SR+Brachytherapy) Arm II (SBRT)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/4 (25.00%)      0/7 (0.00%)    
General disorders     
Death NOS  1  1/4 (25.00%)  1 0/7 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAEV4.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I (SR+Brachytherapy) Arm II (SBRT)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/4 (75.00%)      4/7 (57.14%)    
Cardiac disorders     
Heart failure  1  1/4 (25.00%)  1 0/7 (0.00%)  0
Endocrine disorders     
Hypothyroidism  1  1/4 (25.00%)  1 0/7 (0.00%)  0
Gastrointestinal disorders     
Esophagitis  1  1/4 (25.00%)  1 0/7 (0.00%)  0
Vomiting  1  1/4 (25.00%)  1 0/7 (0.00%)  0
General disorders     
Edema limbs  1  1/4 (25.00%)  1 0/7 (0.00%)  0
Fatigue  1  2/4 (50.00%)  2 1/7 (14.29%)  1
Pain  1  1/4 (25.00%)  1 0/7 (0.00%)  0
Infections and infestations     
Lung infection  1  1/4 (25.00%)  2 0/7 (0.00%)  0
Wound infection  1  1/4 (25.00%)  1 0/7 (0.00%)  0
Investigations     
Carbon monoxide diffusing capacity decreased  1  0/4 (0.00%)  0 1/7 (14.29%)  1
Forced expiratory volume decreased  1  0/4 (0.00%)  0 1/7 (14.29%)  1
Vital capacity abnormal  1  0/4 (0.00%)  0 1/7 (14.29%)  1
Musculoskeletal and connective tissue disorders     
Chest wall pain  1  1/4 (25.00%)  2 1/7 (14.29%)  2
Psychiatric disorders     
Depression  1  1/4 (25.00%)  1 0/7 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Aspiration  1  1/4 (25.00%)  1 0/7 (0.00%)  0
Cough  1  3/4 (75.00%)  8 3/7 (42.86%)  4
Dyspnea  1  0/4 (0.00%)  0 1/7 (14.29%)  1
Hoarseness  1  0/4 (0.00%)  0 1/7 (14.29%)  1
Hypoxia  1  2/4 (50.00%)  6 0/7 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAEV4.0
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Hiran C. Fernando, MD
Organization: Boston Medical Center
Phone: 617-638-5600
EMail: hiran.fernando@bmc.org
Layout table for additonal information
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT01336894    
Other Study ID Numbers: Z4099
U10CA076001 ( U.S. NIH Grant/Contract )
NCI-2011-02667 ( Registry Identifier: NCI Clinical Trials Reporting Office )
CDR0000698986 ( Registry Identifier: Physician Data Query )
First Submitted: April 15, 2011
First Posted: April 18, 2011
Results First Submitted: November 28, 2016
Results First Posted: March 28, 2017
Last Update Posted: May 30, 2017