Trial Outcomes & Findings for 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 (NCT NCT01336894)
NCT ID: NCT01336894
Last Updated: 2017-05-30
Results Overview
Overall survival is defined as the time from randomization until death from any cause.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
13 participants
Primary outcome timeframe
Up to 3 years post-randomization
Results posted on
2017-05-30
Participant Flow
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.
Two participants on Arm I refused/withdrew prior to beginning of protocol interventions. These two participants were excluded from all analyses.
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Protocol Interventions
STARTED
|
4
|
7
|
|
Protocol Interventions
COMPLETED
|
4
|
7
|
|
Protocol Interventions
NOT COMPLETED
|
0
|
0
|
|
Follow-up
STARTED
|
4
|
7
|
|
Follow-up
COMPLETED
|
2
|
0
|
|
Follow-up
NOT COMPLETED
|
2
|
7
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
Follow-up
Study terminated prematurely
|
2
|
7
|
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Arm I (SR+Brachytherapy)
n=4 Participants
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)
n=7 Participants
Patients undergo 3 fractions of stereotactic body radiation therapy (SBRT) at 2-8 days apart.
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65 years
n=5 Participants
|
68 years
n=7 Participants
|
68 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0=Asymptomatic and fully active
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1=Symptomatic and fully ambulatory
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Institutional intent to use brachytherapy
Yes
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Institutional intent to use brachytherapy
No
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Baseline diffusing capacity of the lung for carbon monoxide (DLCO)
|
46 Percentage of predicted
n=5 Participants
|
43 Percentage of predicted
n=7 Participants
|
44 Percentage of predicted
n=5 Participants
|
|
Baseline Forced Expiratory Volume in 1 second (FEV1)
|
42 Percentage of predicted
n=5 Participants
|
92 Percentage of predicted
n=7 Participants
|
54 Percentage of predicted
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 3 years post-randomizationPopulation: Study terminated prematurely. Planned analyses was not performed due to the nature of the closure endpoint data is not available.
Overall survival is defined as the time from randomization until death from any cause.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 years post-randomizationPopulation: Study terminated prematurely. Planned analyses was not performed due to the nature of the closure endpoint data is not available.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 month post-therapyPopulation: All enrolled participants who received protocol interventions and had adverse events reported at 1 month post-therapy.
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.
Outcome measures
| Measure |
Arm I (SR+Brachytherapy)
n=4 Participants
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)
n=7 Participants
Patients undergo 3 fractions of stereotactic body radiation therapy (SBRT) at 2-8 days apart.
|
|---|---|---|
|
Adverse Event Profiles at 1 Month Post-therapy
Chest wall pain · Grade 0
|
3 Participants
|
7 Participants
|
|
Adverse Event Profiles at 1 Month Post-therapy
Chest wall pain · Grade 1
|
1 Participants
|
0 Participants
|
|
Adverse Event Profiles at 1 Month Post-therapy
Chest wall pain · Grade 2
|
0 Participants
|
0 Participants
|
|
Adverse Event Profiles at 1 Month Post-therapy
Cough · Grade 0
|
3 Participants
|
5 Participants
|
|
Adverse Event Profiles at 1 Month Post-therapy
Cough · Grade 1
|
1 Participants
|
2 Participants
|
|
Adverse Event Profiles at 1 Month Post-therapy
Cough · Grade 2
|
0 Participants
|
0 Participants
|
|
Adverse Event Profiles at 1 Month Post-therapy
Dyspnea · Grade 0
|
4 Participants
|
6 Participants
|
|
Adverse Event Profiles at 1 Month Post-therapy
Dyspnea · Grade 1
|
0 Participants
|
1 Participants
|
|
Adverse Event Profiles at 1 Month Post-therapy
Dyspnea · Grade 2
|
0 Participants
|
0 Participants
|
|
Adverse Event Profiles at 1 Month Post-therapy
Hoarness · Grade 0
|
4 Participants
|
6 Participants
|
|
Adverse Event Profiles at 1 Month Post-therapy
Hoarness · Grade 1
|
0 Participants
|
1 Participants
|
|
Adverse Event Profiles at 1 Month Post-therapy
Hoarness · Grade 2
|
0 Participants
|
0 Participants
|
|
Adverse Event Profiles at 1 Month Post-therapy
Hypoxia · Grade 0
|
3 Participants
|
7 Participants
|
|
Adverse Event Profiles at 1 Month Post-therapy
Hypoxia · Grade 1
|
0 Participants
|
0 Participants
|
|
Adverse Event Profiles at 1 Month Post-therapy
Hypoxia · Grade 2
|
1 Participants
|
0 Participants
|
|
Adverse Event Profiles at 1 Month Post-therapy
Fatigue · Grade 0
|
4 Participants
|
6 Participants
|
|
Adverse Event Profiles at 1 Month Post-therapy
Fatigue · Grade 1
|
0 Participants
|
0 Participants
|
|
Adverse Event Profiles at 1 Month Post-therapy
Fatigue · Grade 2
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 3 months post-therapyPopulation: All enrolled participants who received protocol interventions and had adverse event reported at months 3 post-therapy.
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.
Outcome measures
| Measure |
Arm I (SR+Brachytherapy)
n=4 Participants
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)
n=6 Participants
Patients undergo 3 fractions of stereotactic body radiation therapy (SBRT) at 2-8 days apart.
|
|---|---|---|
|
Adverse Event Profiles at 3 Months Post-therapy
Cough · Grade 0
|
3 Participants
|
4 Participants
|
|
Adverse Event Profiles at 3 Months Post-therapy
Cough · Grade 1
|
1 Participants
|
2 Participants
|
|
Adverse Event Profiles at 3 Months Post-therapy
Cough · Grade 2
|
0 Participants
|
0 Participants
|
|
Adverse Event Profiles at 3 Months Post-therapy
Hypoxia · Grade 0
|
3 Participants
|
6 Participants
|
|
Adverse Event Profiles at 3 Months Post-therapy
Hypoxia · Grade 1
|
0 Participants
|
0 Participants
|
|
Adverse Event Profiles at 3 Months Post-therapy
Hypoxia · Grade 2
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 months post-therapyPopulation: Study terminated prematurely. Planned analyses was not performed due to the nature of the closure endpoint data is not available.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 years post-randomizationPopulation: Study terminated prematurely. Planned analyses was not performed due to the nature of the closure endpoint data is not available.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 12 months post-therapyPopulation: Study terminated prematurely. Planned analyses was not performed due to the nature of the closure endpoint data is not available.
Pulmonary function test values include forced expiratory volume 1 (FEV1), carbon monoxide diffusion (DLCO) and forced vital capacity (FVC).
Outcome measures
Outcome data not reported
Adverse Events
Arm I (SR+Brachytherapy)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm II (SBRT)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I (SR+Brachytherapy)
n=4 participants at risk
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)
n=7 participants at risk
Patients undergo 3 fractions of stereotactic body radiation therapy (SBRT) at 2-8 days apart.
|
|---|---|---|
|
General disorders
Death NOS
|
25.0%
1/4 • Number of events 1 • 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 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.
|
0.00%
0/7 • 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 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.
|
Other adverse events
| Measure |
Arm I (SR+Brachytherapy)
n=4 participants at risk
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)
n=7 participants at risk
Patients undergo 3 fractions of stereotactic body radiation therapy (SBRT) at 2-8 days apart.
|
|---|---|---|
|
Cardiac disorders
Heart failure
|
25.0%
1/4 • Number of events 1 • 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 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.
|
0.00%
0/7 • 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 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.
|
|
Endocrine disorders
Hypothyroidism
|
25.0%
1/4 • Number of events 1 • 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 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.
|
0.00%
0/7 • 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 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.
|
|
Gastrointestinal disorders
Esophagitis
|
25.0%
1/4 • Number of events 1 • 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 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.
|
0.00%
0/7 • 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 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.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • Number of events 1 • 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 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.
|
0.00%
0/7 • 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 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.
|
|
General disorders
Edema limbs
|
25.0%
1/4 • Number of events 1 • 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 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.
|
0.00%
0/7 • 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 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.
|
|
General disorders
Fatigue
|
50.0%
2/4 • Number of events 2 • 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 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.
|
14.3%
1/7 • Number of events 1 • 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 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.
|
|
General disorders
Pain
|
25.0%
1/4 • Number of events 1 • 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 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.
|
0.00%
0/7 • 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 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.
|
|
Infections and infestations
Lung infection
|
25.0%
1/4 • Number of events 2 • 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 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.
|
0.00%
0/7 • 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 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.
|
|
Infections and infestations
Wound infection
|
25.0%
1/4 • Number of events 1 • 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 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.
|
0.00%
0/7 • 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 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.
|
|
Investigations
Carbon monoxide diffusing capacity decreased
|
0.00%
0/4 • 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 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.
|
14.3%
1/7 • Number of events 1 • 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 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.
|
|
Investigations
Forced expiratory volume decreased
|
0.00%
0/4 • 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 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.
|
14.3%
1/7 • Number of events 1 • 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 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.
|
|
Investigations
Vital capacity abnormal
|
0.00%
0/4 • 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 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.
|
14.3%
1/7 • Number of events 1 • 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 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.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
25.0%
1/4 • Number of events 2 • 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 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.
|
14.3%
1/7 • Number of events 2 • 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 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.
|
|
Psychiatric disorders
Depression
|
25.0%
1/4 • Number of events 1 • 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 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.
|
0.00%
0/7 • 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 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.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
25.0%
1/4 • Number of events 1 • 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 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.
|
0.00%
0/7 • 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 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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
75.0%
3/4 • Number of events 8 • 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 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.
|
42.9%
3/7 • Number of events 4 • 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 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.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/4 • 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 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.
|
14.3%
1/7 • Number of events 1 • 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 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.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/4 • 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 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.
|
14.3%
1/7 • Number of events 1 • 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 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.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
50.0%
2/4 • Number of events 6 • 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 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.
|
0.00%
0/7 • 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 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60