Trial Outcomes & Findings for Prognostic Study of Metastases in Patients With Stage I, Stage II, or Stage III Non-small Cell Lung Cancer That Can Be Removed by Surgery (NCT NCT00003901)
NCT ID: NCT00003901
Last Updated: 2017-02-16
Results Overview
Overall survival was defined as the time period between patient registration and death. All histologically negative lymph nodes (N0) participants were examined for occult metastases (OM), diagnosed by cytokeratin immunohistochemistry (IHC).
COMPLETED
PHASE3
1310 participants
Up to 5 years
2017-02-16
Participant Flow
One thousand-three hundred and ten participants were enrolled between July 1999 and March 2004. Data was analyzed in June 2009 when all eligible participants could have been observed for at least 5 years.
Two-hundred and sixty-three participants were ultimately removed from the study for various reasons (e.g. initially ineligible, final histology other than non-small-cell lung cancer), leaving 1047 participants evaluable for study endpoints.
Participant milestones
| Measure |
Surgery
All patients undergo complete lymph node sampling or dissection. Patients are followed at 1, 4, 8, and 12 months, every 6 months for 2 years, and then annually for 2 years.
|
|---|---|
|
Overall Study
STARTED
|
1047
|
|
Overall Study
COMPLETED
|
1030
|
|
Overall Study
NOT COMPLETED
|
17
|
Reasons for withdrawal
| Measure |
Surgery
All patients undergo complete lymph node sampling or dissection. Patients are followed at 1, 4, 8, and 12 months, every 6 months for 2 years, and then annually for 2 years.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Ineligible
|
6
|
|
Overall Study
CT Scan not within protocol requirement
|
2
|
|
Overall Study
Chest X-Ray not done prior registration
|
1
|
|
Overall Study
Medical problems
|
6
|
Baseline Characteristics
Prognostic Study of Metastases in Patients With Stage I, Stage II, or Stage III Non-small Cell Lung Cancer That Can Be Removed by Surgery
Baseline characteristics by cohort
| Measure |
Surgery
n=1047 Participants
All patients undergo complete lymph node sampling or dissection. Patients are followed at 1, 4, 8, and 12 months, every 6 months for 2 years, and then annually for 2 years.
|
|---|---|
|
Age, Continuous
|
67.2 years
n=5 Participants
|
|
Gender
Female
|
509 Participants
n=5 Participants
|
|
Gender
Male
|
538 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
959 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
60 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaska Native
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
177 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
870 participants
n=5 Participants
|
|
Operation performed (pulmonary resection)
Exploration, no resection
|
16 Participants
n=5 Participants
|
|
Operation performed (pulmonary resection)
Wedge resection
|
24 Participants
n=5 Participants
|
|
Operation performed (pulmonary resection)
Segmentectomy
|
79 Participants
n=5 Participants
|
|
Operation performed (pulmonary resection)
Lobectomy
|
832 Participants
n=5 Participants
|
|
Operation performed (pulmonary resection)
Bilobectomy
|
51 Participants
n=5 Participants
|
|
Operation performed (pulmonary resection)
Pneumonectomy
|
71 Participants
n=5 Participants
|
|
Additional components of resection
Chest wall resection +/- reconstruction
|
33 Participants
n=5 Participants
|
|
Additional components of resection
Bronchial sleeve resection
|
33 Participants
n=5 Participants
|
|
Additional components of resection
Vascular sleeve resection/arterioplasty
|
13 Participants
n=5 Participants
|
|
Additional components of resection
Intrapericardial resection
|
20 Participants
n=5 Participants
|
|
Extent of resection
R0
|
996 Participants
n=5 Participants
|
|
Extent of resection
R1
|
31 Participants
n=5 Participants
|
|
Extent of resection
R2
|
20 Participants
n=5 Participants
|
|
Tumor histology
Adenocarcinoma
|
524 Participants
n=5 Participants
|
|
Tumor histology
Squamous cell carcinoma
|
318 Participants
n=5 Participants
|
|
Tumor histology
Large cell
|
54 Participants
n=5 Participants
|
|
Tumor histology
Adenosquamous
|
14 Participants
n=5 Participants
|
|
Tumor histology
Non-small-cell lung cancer, other subtype or other
|
137 Participants
n=5 Participants
|
|
Pathologic T Stage
Not available
|
2 Participants
n=5 Participants
|
|
Pathologic T Stage
T1=Tumor<=3cm, surrounded by lung/visceral pleura
|
384 Participants
n=5 Participants
|
|
Pathologic T Stage
T2=Tumor > 3 cm, main bronchus, >=2cm distal to ca
|
575 Participants
n=5 Participants
|
|
Pathologic T Stage
T3=Tumor of any size directly invades certain area
|
55 Participants
n=5 Participants
|
|
Pathologic T Stage
T4=Tumor of any size that invades certain area
|
29 Participants
n=5 Participants
|
|
Pathologic T Stage
TX=Primary tumor cannot be assessed
|
2 Participants
n=5 Participants
|
|
Pathologic N Stage
N0
|
739 Participants
n=5 Participants
|
|
Pathologic N Stage
N1
|
171 Participants
n=5 Participants
|
|
Pathologic N Stage
N2
|
129 Participants
n=5 Participants
|
|
Pathologic N Stage
NX
|
8 Participants
n=5 Participants
|
|
Overall Pathologic Stage
IA
|
324 Participants
n=5 Participants
|
|
Overall Pathologic Stage
IB
|
367 Participants
n=5 Participants
|
|
Overall Pathologic Stage
IIA
|
32 Participants
n=5 Participants
|
|
Overall Pathologic Stage
IIB
|
158 Participants
n=5 Participants
|
|
Overall Pathologic Stage
IIIA
|
137 Participants
n=5 Participants
|
|
Overall Pathologic Stage
IIIB
|
29 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 5 yearsPopulation: Eligible participants with N0 non-small-cell lung cancer who had underwent pulmonary resection and were examined for OM
Overall survival was defined as the time period between patient registration and death. All histologically negative lymph nodes (N0) participants were examined for occult metastases (OM), diagnosed by cytokeratin immunohistochemistry (IHC).
Outcome measures
| Measure |
OM Negative in Lymph Nodes
n=450 Participants
Participants who did not have OM in lymph nodes.
|
OM Positive in Lymph Nodes
n=130 Participants
Participants who had OM in lymph nodes.
|
|---|---|---|
|
Overall Survival in Lymph Nodes Examined Patients
|
NA years
Median survival and 95%CI are not attainable
|
NA years
Median survival and 95%CI are not attainable
|
PRIMARY outcome
Timeframe: Up to 5 yearsPopulation: Eligible participants who had underwent pulmonary resection with rib bone marrow were examined for OM
Overall survival was defined as the time period between patient registration and death. Rib bone marrow on participants were examined for occult metastases (OM), diagnosed by cytokeratin immunohistochemistry (IHC).
Outcome measures
| Measure |
OM Negative in Lymph Nodes
n=755 Participants
Participants who did not have OM in lymph nodes.
|
OM Positive in Lymph Nodes
n=66 Participants
Participants who had OM in lymph nodes.
|
|---|---|---|
|
Overall Survival in Bone Marrow Examined Patients
|
NA years
Median survival and 95% CI are not attainable.
|
NA years
Interval 3.87 to
Median survival and upper limit of 95% CI are not attainable.
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Eligible participants with N0 non-small-cell lung cancer who had underwent pulmonary resection and were examined for OM
Disease-free survival was defined as the time period from registration to the date of first evidence recurrent disease in patients following curative pulmonary resection or death. All histologically negative lymph nodes (N0) participants were examined for occult metastases (OM), diagnosed by cytokeratin immunohistochemistry (IHC).
Outcome measures
| Measure |
OM Negative in Lymph Nodes
n=450 Participants
Participants who did not have OM in lymph nodes.
|
OM Positive in Lymph Nodes
n=130 Participants
Participants who had OM in lymph nodes.
|
|---|---|---|
|
Disease-Free Survival in Lymph Nodes Examined Patients
|
NA years
Median survival and 95%CI are not attainable.
|
NA years
Median survival and 95%CI are not attainable.
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Eligible participants who had underwent pulmonary resection with rib bone marrow were examined for OM
Disease-free survival was defined as the time period from registration to the date of first evidence recurrent disease in patients following curative pulmonary resection or death. Rib bone marrow on participants were examined for occult metastases (OM), diagnosed by cytokeratin immunohistochemistry (IHC).
Outcome measures
| Measure |
OM Negative in Lymph Nodes
n=755 Participants
Participants who did not have OM in lymph nodes.
|
OM Positive in Lymph Nodes
n=66 Participants
Participants who had OM in lymph nodes.
|
|---|---|---|
|
Disease-Free Survival in Bone Marrow Examined Patients
|
NA years
Median survival and 95% CI are not attainable.
|
NA years
Interval 4.82 to
Median survival and upper limit of 95% CI are not attainable.
|
Adverse Events
Surgery
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Valerie Rusch, MD
Memorial Sloan Kettering Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60