Trial Outcomes & Findings for Randomized Study to Compare CyberKnife to Surgical Resection In Stage I Non-small Cell Lung Cancer (NCT NCT00840749)
NCT ID: NCT00840749
Last Updated: 2020-07-14
Results Overview
The study power was calculated for sample size of 420 patients, enrolled over 7 years. The actual enrollment was 36 patients over 4 years. The study was therefore terminated due to lack of enrollment. The sample size does not allow to analysis of the primary outcome. While the study data is not mature enough to evaluate the endpoints of the study, we will attempt to describe the results gleaned from the existing patient population.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
36 participants
Primary outcome timeframe
3 years
Results posted on
2020-07-14
Participant Flow
Participant milestones
| Measure |
CyberKnife Stereotactic Radiotherapy
CyberKnife Stereotactic Radiotherapy: Central lesion dose/fractionation: 15 Gy x 4 fractions = 60 Gy; Peripheral lesion dose/fractionation: 20 Gy x 3 fractions = 60 Gy
|
Surgery
Surgery: 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
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
27
|
|
Overall Study
Treatment
|
20
|
16
|
|
Overall Study
1 Month Post tx
|
19
|
15
|
|
Overall Study
6 Months Post tx
|
16
|
10
|
|
Overall Study
12 Months Post tx
|
14
|
7
|
|
Overall Study
18 Months Post tx
|
12
|
6
|
|
Overall Study
24 Months Post tx
|
9
|
3
|
|
Overall Study
36 Months Post tx
|
1
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
31
|
27
|
Reasons for withdrawal
| Measure |
CyberKnife Stereotactic Radiotherapy
CyberKnife Stereotactic Radiotherapy: Central lesion dose/fractionation: 15 Gy x 4 fractions = 60 Gy; Peripheral lesion dose/fractionation: 20 Gy x 3 fractions = 60 Gy
|
Surgery
Surgery: 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
|
|---|---|---|
|
Overall Study
Death
|
1
|
2
|
|
Overall Study
not treated on study arm
|
11
|
11
|
|
Overall Study
study closed
|
19
|
14
|
Baseline Characteristics
Randomized Study to Compare CyberKnife to Surgical Resection In Stage I Non-small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
CyberKnife Stereotactic Radiotherapy
n=20 Participants
CyberKnife Stereotactic Radiotherapy: Central lesion dose/fractionation: 15 Gy x 4 fractions = 60 Gy; Peripheral lesion dose/fractionation: 20 Gy x 3 fractions = 60 Gy
|
Surgery
n=16 Participants
Surgery: 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
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Age, Continuous
|
67.5 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
67.8 years
STANDARD_DEVIATION 9.9 • n=7 Participants
|
67.7 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
ECOG/Zubrod performance status
0
|
14 participants
n=5 Participants
|
12 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
ECOG/Zubrod performance status
1
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
ECOG/Zubrod performance status
2
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
ECOG/Zubrod performance status
3
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
ECOG/Zubrod performance status
4
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
ECOG/Zubrod performance status
5
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
ECOG/Zubrod performance status
Missing
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Primary Tumour stage
T1a
|
11 participants
n=5 Participants
|
10 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Primary Tumour stage
T1b
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Primary Tumour stage
T2a
|
4 participants
n=5 Participants
|
1 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Lesion Type
Peripheral
|
16 participants
n=5 Participants
|
12 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Lesion Type
Central
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: At the time of study closure, 20 patients were treated on the CyberKnife arm and 16 on the Surgery arm. Two deaths were captured on the Surgery arm during the course of the study and one patient enrolled on the CyberKnife arm passed away before being treated with CyberKnife.
The study power was calculated for sample size of 420 patients, enrolled over 7 years. The actual enrollment was 36 patients over 4 years. The study was therefore terminated due to lack of enrollment. The sample size does not allow to analysis of the primary outcome. While the study data is not mature enough to evaluate the endpoints of the study, we will attempt to describe the results gleaned from the existing patient population.
Outcome measures
| Measure |
CyberKnife Stereotactic Radiotherapy
n=20 Participants
CyberKnife Stereotactic Radiotherapy: Central lesion dose/fractionation: 15 Gy x 4 fractions = 60 Gy; Peripheral lesion dose/fractionation: 20 Gy x 3 fractions = 60 Gy
|
Surgery
n=16 Participants
Surgery: 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
|
|---|---|---|
|
Overall Survival
|
19 Participants
|
14 Participants
|
POST_HOC outcome
Timeframe: 3 yearsPopulation: No patients randomized in either treatment arm made it to 3 years follow-up. No further data was collected or will be collected on the patient population.
While the study data is not mature enough to evaluate the endpoints of the study, we will attempt to describe the results gleaned from the existing patient population.
Outcome measures
| Measure |
CyberKnife Stereotactic Radiotherapy
n=20 Participants
CyberKnife Stereotactic Radiotherapy: Central lesion dose/fractionation: 15 Gy x 4 fractions = 60 Gy; Peripheral lesion dose/fractionation: 20 Gy x 3 fractions = 60 Gy
|
Surgery
n=16 Participants
Surgery: 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
|
|---|---|---|
|
Patient Characteristics
Age: 50-59
|
1 Participants
|
3 Participants
|
|
Patient Characteristics
Pts enrolled at MD Anderson
|
12 Participants
|
10 Participants
|
|
Patient Characteristics
Pts enrolled from other sites
|
8 Participants
|
6 Participants
|
|
Patient Characteristics
Age: 40-49
|
2 Participants
|
0 Participants
|
|
Patient Characteristics
Age: 60-69
|
8 Participants
|
8 Participants
|
|
Patient Characteristics
Age: 70-79
|
7 Participants
|
2 Participants
|
|
Patient Characteristics
Age: 80-89
|
2 Participants
|
3 Participants
|
|
Patient Characteristics
Male
|
10 Participants
|
7 Participants
|
|
Patient Characteristics
Female
|
10 Participants
|
9 Participants
|
|
Patient Characteristics
Central Tumor
|
4 Participants
|
4 Participants
|
|
Patient Characteristics
Peripheral Tumor
|
16 Participants
|
12 Participants
|
|
Patient Characteristics
T1a
|
11 Participants
|
10 Participants
|
|
Patient Characteristics
T1b
|
5 Participants
|
5 Participants
|
|
Patient Characteristics
T2a
|
4 Participants
|
1 Participants
|
Adverse Events
CyberKnife Stereotactic Radiotherapy
Serious events: 0 serious events
Other events: 7 other events
Deaths: 1 deaths
Surgery
Serious events: 2 serious events
Other events: 2 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
CyberKnife Stereotactic Radiotherapy
n=20 participants at risk
CyberKnife Stereotactic Radiotherapy: Central lesion dose/fractionation: 15 Gy x 4 fractions = 60 Gy; Peripheral lesion dose/fractionation: 20 Gy x 3 fractions = 60 Gy
|
Surgery
n=16 participants at risk
Surgery: 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
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Insufficiency
|
0.00%
0/20 • 3 years
|
6.2%
1/16 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/20 • 3 years
|
6.2%
1/16 • Number of events 1 • 3 years
|
Other adverse events
| Measure |
CyberKnife Stereotactic Radiotherapy
n=20 participants at risk
CyberKnife Stereotactic Radiotherapy: Central lesion dose/fractionation: 15 Gy x 4 fractions = 60 Gy; Peripheral lesion dose/fractionation: 20 Gy x 3 fractions = 60 Gy
|
Surgery
n=16 participants at risk
Surgery: 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
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Chest Wall Pain
|
10.0%
2/20 • Number of events 2 • 3 years
|
0.00%
0/16 • 3 years
|
|
Blood and lymphatic system disorders
Lower Limb Arteritus
|
5.0%
1/20 • Number of events 1 • 3 years
|
0.00%
0/16 • 3 years
|
|
Gastrointestinal disorders
Indigestion
|
5.0%
1/20 • Number of events 1 • 3 years
|
0.00%
0/16 • 3 years
|
|
Infections and infestations
Infection- sore throat
|
5.0%
1/20 • Number of events 1 • 3 years
|
0.00%
0/16 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Rib Fracture
|
5.0%
1/20 • Number of events 1 • 3 years
|
0.00%
0/16 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
5.0%
1/20 • Number of events 2 • 3 years
|
0.00%
0/16 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Organ System Failure
|
0.00%
0/20 • 3 years
|
6.2%
1/16 • Number of events 6 • 3 years
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
0.00%
0/20 • 3 years
|
6.2%
1/16 • Number of events 1 • 3 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place