Trial Outcomes & Findings for Stereotactic Body Radiation Therapy in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer That Can Be Removed By Surgery (NCT NCT00551369)
NCT ID: NCT00551369
Last Updated: 2019-04-30
Results Overview
Primary tumor control is defined as the absence of primary tumor failure by 2 years after the start of SBRT. Primary tumor failure was considered as the development of either failure within the SBRT treatment fields (in-field failure) or failure within 1.0 cm of the treatment field (marginal failure). An acceptable tumor control rate at 2 years was considered to be 90% (monthly hazard of 0.00439), and an unacceptable rate was 70% (monthly hazard of 0.01486). A one-sided type 1 error of 0.05 and statistical power of 90% was used. A one-sided Z-test was used to determine if the difference between the logarithm of the observed hazard rate and the logarithm of the hypothesized hazard rate of 0.01486 was statistically significant.
COMPLETED
PHASE2
33 participants
From start of treatment to 2 years.
2019-04-30
Participant Flow
Participant milestones
| Measure |
SBRT
Stereotactic body radiation therapy (SBRT) delivered in 3 fractions of 20 Gy/fraction over 1.5 to 2 weeks for a total of 60 Gy
|
|---|---|
|
Overall Study
STARTED
|
33
|
|
Overall Study
COMPLETED
|
26
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
SBRT
Stereotactic body radiation therapy (SBRT) delivered in 3 fractions of 20 Gy/fraction over 1.5 to 2 weeks for a total of 60 Gy
|
|---|---|
|
Overall Study
Protocol Violation
|
5
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Not treated per protocol and re
|
1
|
Baseline Characteristics
Stereotactic Body Radiation Therapy in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer That Can Be Removed By Surgery
Baseline characteristics by cohort
| Measure |
SBRT
n=26 Participants
Stereotactic body radiation therapy (SBRT) delivered in 3 fractions of 20 Gy/fraction over 1.5 to 2 weeks for a total of 60 Gy
|
|---|---|
|
Age, Continuous
|
73 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From start of treatment to 2 years.Population: All eligible patients who started study treatment
Primary tumor control is defined as the absence of primary tumor failure by 2 years after the start of SBRT. Primary tumor failure was considered as the development of either failure within the SBRT treatment fields (in-field failure) or failure within 1.0 cm of the treatment field (marginal failure). An acceptable tumor control rate at 2 years was considered to be 90% (monthly hazard of 0.00439), and an unacceptable rate was 70% (monthly hazard of 0.01486). A one-sided type 1 error of 0.05 and statistical power of 90% was used. A one-sided Z-test was used to determine if the difference between the logarithm of the observed hazard rate and the logarithm of the hypothesized hazard rate of 0.01486 was statistically significant.
Outcome measures
| Measure |
SBRT
n=26 Participants
Stereotactic body radiation therapy (SBRT) delivered in 3 fractions of 20 Gy/fraction over 1.5 to 2 weeks for a total of 60 Gy
|
|---|---|
|
Primary Tumor Control at 2 Years
|
96.2 percentage of patients
Interval 83.2 to 99.7
|
SECONDARY outcome
Timeframe: From start of treatment to end of follow-up. Analysis can occur at or after time of primary outcome measure analysis.Population: All eligible patients who started study treatment
The development of any treatment-related toxicity from among the following: Gastrointestinal: dysphagia, esophagitis, esophageal stricture/stenosis, esophageal ulceration; Cardiac: pericarditis, pericardial effusion, restrictive cardiomyopathy, ventricular dysfunction (left ventricular diastolic dysfunction, left ventricular systolic dysfunction, right ventricular dysfunction); Neurologic: myelitis, neuropathy (cranial and motor); Hemorrhage: pulmonary or upper respiratory; Pulmonary: decline in pulmonary function as measured by pulmonary function tests (DLCO, FEV1,FVC), pneumonitis, pulmonary fibrosis, hypoxia, pleural effusion, cough, and dyspnea; Any grade 4 or 5 adverse event attributed to the therapy
Outcome measures
| Measure |
SBRT
n=26 Participants
Stereotactic body radiation therapy (SBRT) delivered in 3 fractions of 20 Gy/fraction over 1.5 to 2 weeks for a total of 60 Gy
|
|---|---|
|
Rate of Treatment-related Grade 3 or 4 Toxicity
|
7.7 percentage of participants
Interval 0.0 to 17.9
|
SECONDARY outcome
Timeframe: From start of treatment to end of follow-up. Analysis can occur at or after time of primary outcome measure analysis.Population: All eligible patients who started study treatment
The development of any treatment-related toxicity not from among the following: Gastrointestinal: dysphagia, esophagitis, esophageal stricture/stenosis, esophageal ulceration; Cardiac: pericarditis, pericardial effusion, restrictive cardiomyopathy, ventricular dysfunction (left ventricular diastolic dysfunction, left ventricular systolic dysfunction, right ventricular dysfunction); Neurologic: myelitis, neuropathy (cranial and motor); Hemorrhage: pulmonary or upper respiratory; Pulmonary: decline in pulmonary function as measured by pulmonary function tests (DLCO, FEV1,FVC), pneumonitis, pulmonary fibrosis, hypoxia, pleural effusion, cough, and dyspnea; Any grade 4 or 5 adverse event attributed to the therapy
Outcome measures
| Measure |
SBRT
n=26 Participants
Stereotactic body radiation therapy (SBRT) delivered in 3 fractions of 20 Gy/fraction over 1.5 to 2 weeks for a total of 60 Gy
|
|---|---|
|
Other Grade 3-5 Adverse Events
|
3.9 percentage of participants
Interval 0.0 to 19.6
|
SECONDARY outcome
Timeframe: From start of treatment to 2 years.Population: All eligible patients who started study treatment
PTF: the development of either failure within the SBRT treatment fields (in-field failure) or failure within 1.0 cm of the treatment field (marginal failure) within the first two years after start of SBRT. RF: the development of measurable tumor within lymph nodes along the natural lymphatic drainage typical for the location of the treated primary disease only with dimension of at least 1.0 cm on imaging studies (preferably CT scans) within the lung, bronchial hilum, or the mediastinum within the first two years after start of SBRT. MD: the appearance after protocol therapy of cancer deposits characteristic of metastatic dissemination from non-small cell lung cancer within the first two years after start of SBRT. DFS: the state of being alive without development of progressive disease, with failure considered the earliest development of either progression or death. OS: the state of being alive, with failure is considered death due to any cause.
Outcome measures
| Measure |
SBRT
n=26 Participants
Stereotactic body radiation therapy (SBRT) delivered in 3 fractions of 20 Gy/fraction over 1.5 to 2 weeks for a total of 60 Gy
|
|---|---|
|
Primary Tumor Failure (PTF), Marginal Failure (MF), Regional Failure (RF), Metastatic Dissemination (MD), Disease-free Survival (DFS), and Overall Survival (OS) at 2 Years
Primary Tumor Failure at 2 Years
|
3.8 percentage of participants
Interval 0.3 to 16.8
|
|
Primary Tumor Failure (PTF), Marginal Failure (MF), Regional Failure (RF), Metastatic Dissemination (MD), Disease-free Survival (DFS), and Overall Survival (OS) at 2 Years
Regional Failure at 2 Years
|
7.7 percentage of participants
Interval 1.3 to 22.1
|
|
Primary Tumor Failure (PTF), Marginal Failure (MF), Regional Failure (RF), Metastatic Dissemination (MD), Disease-free Survival (DFS), and Overall Survival (OS) at 2 Years
Metastatic Dissemination at 2 Years
|
11.5 percentage of participants
Interval 2.8 to 27.1
|
|
Primary Tumor Failure (PTF), Marginal Failure (MF), Regional Failure (RF), Metastatic Dissemination (MD), Disease-free Survival (DFS), and Overall Survival (OS) at 2 Years
Disease-Free Survival at 2 Years
|
73.1 percentage of participants
Interval 51.7 to 86.2
|
|
Primary Tumor Failure (PTF), Marginal Failure (MF), Regional Failure (RF), Metastatic Dissemination (MD), Disease-free Survival (DFS), and Overall Survival (OS) at 2 Years
Overall Survival at 2 Years
|
84.6 percentage of participants
Interval 64.0 to 93.9
|
SECONDARY outcome
Timeframe: From start of treatment to end of follow-up.Population: The data required for this analysis was not obtained and will not be obtained.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From start of treatment to 2 years.Population: The data required for this analysis was not obtained and will not be obtained.
Assess if blood markers prior to, during the course of treatment (between the second and the last dose of SBRT), and at the first follow-up after SBRT predict 2 year primary tumor control and predict for grade ≥ 2 treatment-related adverse events. Unfortunately, there were not enough specimens submitted to perform this analysis. The specimens that were collected remain in the NRG Oncology Biobank and are available to be combined with other specimens from other studies for an appropriately powered project.
Outcome measures
Outcome data not reported
Adverse Events
SBRT
Serious adverse events
| Measure |
SBRT
n=26 participants at risk
Stereotactic body radiation therapy (SBRT) delivered in 3 fractions of 20 Gy/fraction over 1.5 to 2 weeks for a total of 60 Gy
|
|---|---|
|
Nervous system disorders
Peripheral sensory neuropathy
|
3.8%
1/26
|
Other adverse events
| Measure |
SBRT
n=26 participants at risk
Stereotactic body radiation therapy (SBRT) delivered in 3 fractions of 20 Gy/fraction over 1.5 to 2 weeks for a total of 60 Gy
|
|---|---|
|
General disorders
Chest pain
|
7.7%
2/26
|
|
General disorders
Fatigue
|
7.7%
2/26
|
|
General disorders
Pain [other]
|
7.7%
2/26
|
|
Infections and infestations
Sinusitis [with unknown ANC]
|
7.7%
2/26
|
|
Injury, poisoning and procedural complications
Fracture
|
7.7%
2/26
|
|
Investigations
Carbon monoxide diffusing capacity decreased
|
50.0%
13/26
|
|
Investigations
Forced expiratory volume decreased
|
7.7%
2/26
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.7%
2/26
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
11.5%
3/26
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
7.7%
2/26
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
7.7%
2/26
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
19.2%
5/26
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
30.8%
8/26
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
15.4%
4/26
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
26.9%
7/26
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
30.8%
8/26
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
11.5%
3/26
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
- Publication restrictions are in place
Restriction type: OTHER