Trial Outcomes & Findings for Stereotactic Body Radiation Therapy (SBRT) for Lung Tumors (NCT NCT00632281)
NCT ID: NCT00632281
Last Updated: 2012-02-20
Results Overview
2-year local control (Percentage of tumors that did not recur at treated site 2 years after treatment), cause-specific survival (percentage of patients who had not died from disease under study in the 2 years since treatment), overall survival (percent of patients still alive at 2 years after treatment), and freedom from failure (percentage of patients in whom the disease treated had not progressed or recurred in the 2 years since treatment)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
38 participants
Primary outcome timeframe
2 yrs
Results posted on
2012-02-20
Participant Flow
Participant milestones
| Measure |
All Patients Receiving SBRT to Thorax
22 patients had Non-small-cell lung cancer (NSCLC), 6 had metastatic disease, and 6 had 2 lesions treated simultaneously.
|
|---|---|
|
Overall Study
STARTED
|
38
|
|
Overall Study
COMPLETED
|
38
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Stereotactic Body Radiation Therapy (SBRT) for Lung Tumors
Baseline characteristics by cohort
| Measure |
All Patients Receiving SBRT to Thorax
n=38 Participants
22 patients had Non-small-cell lung cancer (NSCLC), 6 had metastatic disease, and 6 had 2 lesions treated simultaneously.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
30 Participants
n=5 Participants
|
|
Age Continuous
|
72.3 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
38 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yrsPopulation: 44 lesions in 38 patients were treated with IMRT or 3D conformal beams on a prospective trial examining thoracic SBRT. Twenty-two of 32 primary lung cancer patients had biopsy-proven NSCLC (stage IA, 21 patients; stage IB, 11 patients). Six had metastatic disease. Six patients had 2 lesions treated simultaneously.
2-year local control (Percentage of tumors that did not recur at treated site 2 years after treatment), cause-specific survival (percentage of patients who had not died from disease under study in the 2 years since treatment), overall survival (percent of patients still alive at 2 years after treatment), and freedom from failure (percentage of patients in whom the disease treated had not progressed or recurred in the 2 years since treatment)
Outcome measures
| Measure |
All Patients Receiving SBRT to the Thorax
n=38 Participants
|
|---|---|
|
Disease Status
Rate of 2-year control
|
84 percentage of participants
|
|
Disease Status
Cause specific survival rate
|
78 percentage of participants
|
|
Disease Status
Overall Survival rate
|
55 percentage of participants
|
|
Disease Status
Freedom from Failure rate
|
54 percentage of participants
|
SECONDARY outcome
Timeframe: up to 2 years, 9 monthsToxicity is defined as adverse events described in the CTCAE (version 3). Acute toxicity refers to adverse events that occurred up until 3 months after treatment and "late" toxicity as those occurring 3 months or longer after the end of treatment. Below are the Rates of grade 2 acute toxicity, grade 3 acute toxicity, late grade 3 toxicity, and late grade 4 toxicity
Outcome measures
| Measure |
All Patients Receiving SBRT to the Thorax
n=38 Participants
|
|---|---|
|
Toxicity ot the Thorax
grade 2 toxicity
|
30 percentage of participants
|
|
Toxicity ot the Thorax
grade 3 toxicity
|
2 percentage of participants
|
|
Toxicity ot the Thorax
late grade 2 toxicity
|
32 percentage of participants
|
|
Toxicity ot the Thorax
late grade 3 toxicity
|
8 percentage of participants
|
Adverse Events
All Patients Receiving SBRT to Thorax
Serious events: 20 serious events
Other events: 38 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Patients Receiving SBRT to Thorax
n=38 participants at risk
22 patients had Non-small-cell lung cancer (NSCLC), 6 had metastatic disease, and 6 had 2 lesions treated simultaneously.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Grade 3 Dermatitis
|
2.6%
1/38 • Number of events 1 • 2 years, 9 months
Adverse events were assessed every 3 weeks for 3 months and then every 3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Grade 3 Dyspnea
|
23.7%
9/38 • Number of events 24 • 2 years, 9 months
Adverse events were assessed every 3 weeks for 3 months and then every 3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Grade 3 FEV1
|
44.7%
17/38 • Number of events 33 • 2 years, 9 months
Adverse events were assessed every 3 weeks for 3 months and then every 3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Grade 4 FEV1
|
5.3%
2/38 • Number of events 3 • 2 years, 9 months
Adverse events were assessed every 3 weeks for 3 months and then every 3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Grade 3 Vital Capacity
|
15.8%
6/38 • Number of events 11 • 2 years, 9 months
Adverse events were assessed every 3 weeks for 3 months and then every 3 months.
|
Other adverse events
| Measure |
All Patients Receiving SBRT to Thorax
n=38 participants at risk
22 patients had Non-small-cell lung cancer (NSCLC), 6 had metastatic disease, and 6 had 2 lesions treated simultaneously.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Grade 1 cough
|
60.5%
23/38 • Number of events 85 • 2 years, 9 months
Adverse events were assessed every 3 weeks for 3 months and then every 3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Grade 2 Cough
|
2.6%
1/38 • Number of events 1 • 2 years, 9 months
Adverse events were assessed every 3 weeks for 3 months and then every 3 months.
|
|
Skin and subcutaneous tissue disorders
Grade 1 Dermatitis
|
55.3%
21/38 • Number of events 41 • 2 years, 9 months
Adverse events were assessed every 3 weeks for 3 months and then every 3 months.
|
|
Skin and subcutaneous tissue disorders
Grade 2 Dermatitis
|
5.3%
2/38 • Number of events 2 • 2 years, 9 months
Adverse events were assessed every 3 weeks for 3 months and then every 3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Grade 1 Dyspnea
|
44.7%
17/38 • Number of events 77 • 2 years, 9 months
Adverse events were assessed every 3 weeks for 3 months and then every 3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Grade 2 Dyspnea
|
28.9%
11/38 • Number of events 61 • 2 years, 9 months
Adverse events were assessed every 3 weeks for 3 months and then every 3 months.
|
|
Gastrointestinal disorders
Grade 1 Esophagitis
|
2.6%
1/38 • Number of events 1 • 2 years, 9 months
Adverse events were assessed every 3 weeks for 3 months and then every 3 months.
|
|
Gastrointestinal disorders
Grade 2 Esophagitis
|
10.5%
4/38 • Number of events 10 • 2 years, 9 months
Adverse events were assessed every 3 weeks for 3 months and then every 3 months.
|
|
Investigations
Grade 1 Fatigue
|
76.3%
29/38 • Number of events 133 • 2 years, 9 months
Adverse events were assessed every 3 weeks for 3 months and then every 3 months.
|
|
Investigations
Grade 2 Fatigue
|
34.2%
13/38 • Number of events 29 • 2 years, 9 months
Adverse events were assessed every 3 weeks for 3 months and then every 3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Grade 1 FEV1
|
21.1%
8/38 • Number of events 16 • 2 years, 9 months
Adverse events were assessed every 3 weeks for 3 months and then every 3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Grade 2 FEV1
|
18.4%
7/38 • Number of events 18 • 2 years, 9 months
Adverse events were assessed every 3 weeks for 3 months and then every 3 months.
|
|
Infections and infestations
Grade 1 Fever
|
2.6%
1/38 • Number of events 1 • 2 years, 9 months
Adverse events were assessed every 3 weeks for 3 months and then every 3 months.
|
|
Gastrointestinal disorders
Grade 1 Nausea
|
42.1%
16/38 • Number of events 22 • 2 years, 9 months
Adverse events were assessed every 3 weeks for 3 months and then every 3 months.
|
|
Gastrointestinal disorders
Grade 2 Nausea
|
2.6%
1/38 • Number of events 1 • 2 years, 9 months
Adverse events were assessed every 3 weeks for 3 months and then every 3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Grade 1 Pleural Effusion
|
7.9%
3/38 • Number of events 8 • 2 years, 9 months
Adverse events were assessed every 3 weeks for 3 months and then every 3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Grade 1 Pneumonitis
|
26.3%
10/38 • Number of events 19 • 2 years, 9 months
Adverse events were assessed every 3 weeks for 3 months and then every 3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Grade 2 Pneumonitis
|
7.9%
3/38 • Number of events 3 • 2 years, 9 months
Adverse events were assessed every 3 weeks for 3 months and then every 3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Grade 1 Pulmonary fibrosis
|
26.3%
10/38 • Number of events 22 • 2 years, 9 months
Adverse events were assessed every 3 weeks for 3 months and then every 3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Grade 2 Pulmonary fibrosis
|
5.3%
2/38 • Number of events 2 • 2 years, 9 months
Adverse events were assessed every 3 weeks for 3 months and then every 3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Grade 1 Vital Capacity
|
23.7%
9/38 • Number of events 16 • 2 years, 9 months
Adverse events were assessed every 3 weeks for 3 months and then every 3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Grade 2 Vital Capacity
|
55.3%
21/38 • Number of events 43 • 2 years, 9 months
Adverse events were assessed every 3 weeks for 3 months and then every 3 months.
|
Additional Information
Bridget Fitzgerald, Clinical Research Coordinator
University of Florida
Phone: 352-265-0680
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place