Trial Outcomes & Findings for Lung Cancer STARS Trial - STARS Revised Clinical Trial Protocol: Stereotactic Ablative Radiotherapy (SABR) in Stage I Non-small Cell Lung Cancer Patients Who Can Undergo Lobectomy (NCT NCT02357992)
NCT ID: NCT02357992
Last Updated: 2022-10-14
Results Overview
OS defined as the length of time measured from the start of treatment until 3 years post-treatment or death, whichever come first.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
122 participants
Primary outcome timeframe
3 years
Results posted on
2022-10-14
Participant Flow
Recruitment Period: April 2010- January 2018.
A total of 122 participants were consented; 6 were screen failures.
Participant milestones
| Measure |
Surgery (S) vs. SBRT
These patients were randomized to surgery vs. SBRT. Both open thoracotomy and video assisted thoracotomy (VATS) are acceptable procedures. Surgery may consist of a lobectomy, sleeve resection, bilobectomy or pneumonectomy as determined by the attending surgeon based on the operative findings. The type of resection chosen should provide complete removal of the primary lesion with negative gross and microscopic margins. Documentation of margins (bronchial and vascular and any other required) by frozen sections at surgery is recommended. Limited resection including wedge or segmental resections should not be performed unless there are unforeseen problems at the time of surgery.
|
Stereotactic Body Radiation Therapy (SBRT) (R)
SBRT for lung cancer utilizes elements of 3-DCRT and also incorporates a variety of systems for taking cancer motion into consideration and decreasing set-up uncertainty using image guided radiotherapy techniques (9). These systems allow reduction of treatment volumes facilitating hypofractionation with markedly increased daily doses (\>10 GY) and a significantly reduced overall treatment time. The combination of multiple beam angles to achieve sharp dose gradients, high precision localization and a high dose per fraction in extracranial locations are referred to as SBRT. This approach delivers a high biological effective dose (BED) to the target while minimizing the normal tissue toxicities, this may translate into improved local control and survival.
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
80
|
|
Overall Study
COMPLETED
|
36
|
80
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lung Cancer STARS Trial - STARS Revised Clinical Trial Protocol: Stereotactic Ablative Radiotherapy (SABR) in Stage I Non-small Cell Lung Cancer Patients Who Can Undergo Lobectomy
Baseline characteristics by cohort
| Measure |
Surgery (S) vs. SBRT
n=36 Participants
These patients were randomized to surgery vs. SBRT. Both open thoracotomy and video assisted thoracotomy (VATS) are acceptable procedures. Surgery may consist of a lobectomy, sleeve resection, bilobectomy or pneumonectomy as determined by the attending surgeon based on the operative findings. The type of resection chosen should provide complete removal of the primary lesion with negative gross and microscopic margins. Documentation of margins (bronchial and vascular and any other required) by frozen sections at surgery is recommended. Limited resection including wedge or segmental resections should not be performed unless there are unforeseen problems at the time of surgery.
|
Stereotactic Body Radiation Therapy (SBRT) (R)
n=80 Participants
SBRT for lung cancer utilizes elements of 3-DCRT and also incorporates a variety of systems for taking cancer motion into consideration and decreasing set-up uncertainty using image guided radiotherapy techniques (9). These systems allow reduction of treatment volumes facilitating hypofractionation with markedly increased daily doses (\>10 GY) and a significantly reduced overall treatment time. The combination of multiple beam angles to achieve sharp dose gradients, high precision localization and a high dose per fraction in extracranial locations are referred to as SBRT. This approach delivers a high biological effective dose (BED) to the target while minimizing the normal tissue toxicities, this may translate into improved local control and survival.
|
Total
n=116 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
38 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
20 Participants
n=93 Participants
|
58 Participants
n=4 Participants
|
78 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=93 Participants
|
36 Participants
n=4 Participants
|
54 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=93 Participants
|
44 Participants
n=4 Participants
|
62 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=93 Participants
|
70 Participants
n=4 Participants
|
84 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
22 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
27 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=93 Participants
|
67 Participants
n=4 Participants
|
94 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
36 participants
n=93 Participants
|
80 participants
n=4 Participants
|
116 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 3 yearsOS defined as the length of time measured from the start of treatment until 3 years post-treatment or death, whichever come first.
Outcome measures
| Measure |
Surgery (S) vs. SBRT
n=36 Participants
These patients were randomized to surgery vs. SBRT. Both open thoracotomy and video assisted thoracotomy (VATS) are acceptable procedures. Surgery may consist of a lobectomy, sleeve resection, bilobectomy or pneumonectomy as determined by the attending surgeon based on the operative findings. The type of resection chosen should provide complete removal of the primary lesion with negative gross and microscopic margins. Documentation of margins (bronchial and vascular and any other required) by frozen sections at surgery is recommended. Limited resection including wedge or segmental resections should not be performed unless there are unforeseen problems at the time of surgery.
|
Stereotactic Body Radiation Therapy (SBRT) (R)
n=80 Participants
SBRT for lung cancer utilizes elements of 3-DCRT and also incorporates a variety of systems for taking cancer motion into consideration and decreasing set-up uncertainty using image guided radiotherapy techniques (9). These systems allow reduction of treatment volumes facilitating hypofractionation with markedly increased daily doses (\>10 GY) and a significantly reduced overall treatment time. The combination of multiple beam angles to achieve sharp dose gradients, high precision localization and a high dose per fraction in extracranial locations are referred to as SBRT. This approach delivers a high biological effective dose (BED) to the target while minimizing the normal tissue toxicities, this may translate into improved local control and survival.
|
|---|---|---|
|
Number of Participants With Overall Survival (OS) at 3 Years
|
31 Participants
|
70 Participants
|
Adverse Events
Surgery (S) vs. SBRT
Serious events: 3 serious events
Other events: 3 other events
Deaths: 5 deaths
Stereotactic Body Radiation Therapy (SBRT) (R)
Serious events: 8 serious events
Other events: 3 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
Surgery (S) vs. SBRT
n=36 participants at risk
These patients were randomized to surgery vs. SBRT. Both open thoracotomy and video assisted thoracotomy (VATS) are acceptable procedures. Surgery may consist of a lobectomy, sleeve resection, bilobectomy or pneumonectomy as determined by the attending surgeon based on the operative findings. The type of resection chosen should provide complete removal of the primary lesion with negative gross and microscopic margins. Documentation of margins (bronchial and vascular and any other required) by frozen sections at surgery is recommended. Limited resection including wedge or segmental resections should not be performed unless there are unforeseen problems at the time of surgery.
|
Stereotactic Body Radiation Therapy (SBRT) (R)
n=80 participants at risk
SBRT for lung cancer utilizes elements of 3-DCRT and also incorporates a variety of systems for taking cancer motion into consideration and decreasing set-up uncertainty using image guided radiotherapy techniques (9). These systems allow reduction of treatment volumes facilitating hypofractionation with markedly increased daily doses (\>10 GY) and a significantly reduced overall treatment time. The combination of multiple beam angles to achieve sharp dose gradients, high precision localization and a high dose per fraction in extracranial locations are referred to as SBRT. This approach delivers a high biological effective dose (BED) to the target while minimizing the normal tissue toxicities, this may translate into improved local control and survival.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Disease progression NOS
|
0.00%
0/36 • Adverse Events were assessed after protocol treatment was initiated until three years post-treatment or death, whichever came first.
|
10.0%
8/80 • Number of events 10 • Adverse Events were assessed after protocol treatment was initiated until three years post-treatment or death, whichever came first.
|
|
Cardiac disorders
Cardiac ischemia/infarction
|
0.00%
0/36 • Adverse Events were assessed after protocol treatment was initiated until three years post-treatment or death, whichever came first.
|
1.2%
1/80 • Number of events 1 • Adverse Events were assessed after protocol treatment was initiated until three years post-treatment or death, whichever came first.
|
|
Infections and infestations
Infection-lung
|
0.00%
0/36 • Adverse Events were assessed after protocol treatment was initiated until three years post-treatment or death, whichever came first.
|
1.2%
1/80 • Number of events 1 • Adverse Events were assessed after protocol treatment was initiated until three years post-treatment or death, whichever came first.
|
|
Investigations
Death, NOS (unknown)
|
8.3%
3/36 • Number of events 3 • Adverse Events were assessed after protocol treatment was initiated until three years post-treatment or death, whichever came first.
|
0.00%
0/80 • Adverse Events were assessed after protocol treatment was initiated until three years post-treatment or death, whichever came first.
|
|
Infections and infestations
Infection-Other (sepsis)
|
2.8%
1/36 • Number of events 1 • Adverse Events were assessed after protocol treatment was initiated until three years post-treatment or death, whichever came first.
|
0.00%
0/80 • Adverse Events were assessed after protocol treatment was initiated until three years post-treatment or death, whichever came first.
|
|
Infections and infestations
Infection-Other (COPD/pulmonary)
|
2.8%
1/36 • Number of events 1 • Adverse Events were assessed after protocol treatment was initiated until three years post-treatment or death, whichever came first.
|
0.00%
0/80 • Adverse Events were assessed after protocol treatment was initiated until three years post-treatment or death, whichever came first.
|
Other adverse events
| Measure |
Surgery (S) vs. SBRT
n=36 participants at risk
These patients were randomized to surgery vs. SBRT. Both open thoracotomy and video assisted thoracotomy (VATS) are acceptable procedures. Surgery may consist of a lobectomy, sleeve resection, bilobectomy or pneumonectomy as determined by the attending surgeon based on the operative findings. The type of resection chosen should provide complete removal of the primary lesion with negative gross and microscopic margins. Documentation of margins (bronchial and vascular and any other required) by frozen sections at surgery is recommended. Limited resection including wedge or segmental resections should not be performed unless there are unforeseen problems at the time of surgery.
|
Stereotactic Body Radiation Therapy (SBRT) (R)
n=80 participants at risk
SBRT for lung cancer utilizes elements of 3-DCRT and also incorporates a variety of systems for taking cancer motion into consideration and decreasing set-up uncertainty using image guided radiotherapy techniques (9). These systems allow reduction of treatment volumes facilitating hypofractionation with markedly increased daily doses (\>10 GY) and a significantly reduced overall treatment time. The combination of multiple beam angles to achieve sharp dose gradients, high precision localization and a high dose per fraction in extracranial locations are referred to as SBRT. This approach delivers a high biological effective dose (BED) to the target while minimizing the normal tissue toxicities, this may translate into improved local control and survival.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/36 • Adverse Events were assessed after protocol treatment was initiated until three years post-treatment or death, whichever came first.
|
1.2%
1/80 • Number of events 1 • Adverse Events were assessed after protocol treatment was initiated until three years post-treatment or death, whichever came first.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/36 • Adverse Events were assessed after protocol treatment was initiated until three years post-treatment or death, whichever came first.
|
1.2%
1/80 • Number of events 1 • Adverse Events were assessed after protocol treatment was initiated until three years post-treatment or death, whichever came first.
|
|
Respiratory, thoracic and mediastinal disorders
Lung fibrosis
|
0.00%
0/36 • Adverse Events were assessed after protocol treatment was initiated until three years post-treatment or death, whichever came first.
|
1.2%
1/80 • Number of events 1 • Adverse Events were assessed after protocol treatment was initiated until three years post-treatment or death, whichever came first.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
2.8%
1/36 • Number of events 1 • Adverse Events were assessed after protocol treatment was initiated until three years post-treatment or death, whichever came first.
|
0.00%
0/80 • Adverse Events were assessed after protocol treatment was initiated until three years post-treatment or death, whichever came first.
|
|
Musculoskeletal and connective tissue disorders
Rib fracture
|
2.8%
1/36 • Number of events 1 • Adverse Events were assessed after protocol treatment was initiated until three years post-treatment or death, whichever came first.
|
0.00%
0/80 • Adverse Events were assessed after protocol treatment was initiated until three years post-treatment or death, whichever came first.
|
|
Infections and infestations
Pneumonia
|
2.8%
1/36 • Number of events 1 • Adverse Events were assessed after protocol treatment was initiated until three years post-treatment or death, whichever came first.
|
0.00%
0/80 • Adverse Events were assessed after protocol treatment was initiated until three years post-treatment or death, whichever came first.
|
Additional Information
Dr. Jack Roth, MD- Professor, Thoracic & Cardio Surgery-Rsch
UT MD Anderson Cancer Center
Phone: (713) 792-7664
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place