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
RATIONALE: Prognostic testing for early signs of metastases may help doctors detect metastases early and plan more effective treatment.
PURPOSE: Phase III trial to study the relationship between early signs of metastases and survival in patients who have stage I, stage II, or stage III non-small cell lung cancer that can be removed by surgery.
Other: immunohistochemistry staining method
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||A Prospective Study of the Prognostic Significance of Occult Metastases in the Patient With Resectable Non-Small Cell Lung Carcinoma|
- overall survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
- disease-free survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||July 1999|
|Study Completion Date:||October 2011|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
All patients undergo complete lymph node sampling or dissection. A small portion of rib is removed at this time. Some patients may have primary tumor completely removed.
Lymph nodes and bone marrow from the rib section are examined for occult metastases using immunohistochemical staining methods and standard staining methods.
Patients are followed at 1, 4, 8, and 12 months, every 6 months for 2 years, and then annually for 2 years.
|Other: immunohistochemistry staining method Procedure: biopsy Procedure: surgery|
- Determine the relationship between three indicators of occult metastases (cytological examination of pleural lavage, immunohistochemistry (IHC) assay of lymph nodes, and IHC assay of rib bone marrow) and survival of patients with resectable non-small cell lung cancer.
- Determine the relationship between these indicators and conventional histology.
- Model survival considering the indicators and other patient attributes that are of prime prognostic significance.
- Determine the relationships between the indicators and the site of first recurrence in these patients.
- Determine the prevalence of the indicators in these patients.
- Determine the relationships between the indicators and disease free survival in these patients.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003901
Show 58 Study Locations
|Study Chair:||Robbin G. Cohen, MD||University of Southern California|